MS Advocacy At The State Capitol

The Virginia chapter of the National Multiple Sclerosis Society (NMMS), of which I am a member, led the way for state advocacy across the country in support of policies that will benefit people living with multiple sclerosis (MS) and other chronic diseases, caregivers and their loved ones, and people who don’t have anyone else to speak up on their behalf.

Becoming an advocate is really easy, and you can take action from home by becoming an MS Activist and signing up for federal action alerts from the National MS Society. But there is something special about traveling to your state capitol, visiting the offices of your state legislatures, speaking your concerns, making your voice heard, and witnessing the legislative process in action if you are fortunate enough to sit in on a meeting of your state congress.

Read this post in its entirety:
Speaking with Your State Legislators about MS: State Action Day in Virginia

Carnival of MS Bloggers #144

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

Other Voices - Why Megan Supports the MS Society

by Rex Parker of Biking MS

The reason I support the National MS Society is well-known to readers of this blog. There are so many other compelling stories from people I'm connected with that I wanted to start sharing them with you...

The more of these stories I hear, I realize that their stories are mine and mine is theirs - we're all connected. So many families struggle to cope with MS. So many of us have lost family members and close friends. I hope that many of you recognize your own struggles in these stories, and get the same sense of support and camaraderie that I do. And a sense of hope that we can all work together to realize a world free of MS.

First off here's my friend Megan Nettleton, Community Relations Specialist for the National MS Society here in Boise. Megan's story is well-known within the MS community here in Boise. Megan is married to Chris Nettleton, the sports director for KBOI Channel 2. Chris suffers from MS, and has been a vocal and active supporter of MS Society events here in town, often lending his talents to emcee events. 

Megan and Chris

Megan's story is interesting to me, as she has a unique personal and professional connection to the MS Society. Here's her story, in her words...

“Before working at the National MS Society, I managed a bank for six years. I was never one to believe that anyone could truly love their job, but I am a believer now. My husband has MS, so it is an amazing feeling going to work and ultimately helping my husband every day! Who else gets to say that they get to do that? And now, it is not just about him anymore, but I now work here for all the amazing people I have met along the way, people like Rex! People that give so much of themselves without a second thought. That is why I support the National MS Society…because they support me!”

Me and Megan at "Meet Me Monday"

Just think about what most people do when faced with an MS diagnosis in the family. Sure, there are phases of anger, denial, depression, etc. But Megan not only went about arming herself with the knowledge she'd need to help and support Chris - but she also went to work for the one organization that will give them the most support during this ongoing fight. Megan has the unenviable task of being a one-person shop here in Boise, and I appreciate the positive energy and dedication she brings to the job.

And, to give you more insight into what Chris and Megan have to deal with, I swiped the following post from Megan's Facebook page. This is something she wrote when raising funds for her Walk MS Boise team...

"I was thinking today that a lot of you probably don't know very much of my husband's story and his multiple sclerosis diagnosis. And here I am asking you for donations quite a bit lately, so I thought I would share a little bit about his journey:

In 2008 his feet went completely numb. His doctor thought it couldn't possibly be MS because it was in both feet equally - so he went through a lot of testing, including electro-shock therapy on his legs, and muscle tests that involved shoving a 3-inch needle into his calves and moving it around to see if his muscles were working properly. Crazy, I know. Then he had an MRI and based on those results, his neurologist told him that he either had a brain tumor or MS. It is weird to say this, but luckily, it was MS and not a brain tumor. 

Because my husband is an all-or-nothing kind of guy, he went on a therapy immediately, which entailed me ramming a 3-inch needle intramuscularly into his thigh. And any of you that know my husband - he is majorly phobic of needles, but this was something we did for the next 2 1/2 years. And then one day he went in for a generic check-up, and surprisingly his liver numbers were way elevated. They discovered that the therapy had started to damage his liver, so he had to immediately go off of it. His only other option at this point for therapy: a DAILY shot. Great. But, my husband bravely endured it for one month, even though he had a severe skin reaction that caused his body to be covered in red, itchy, sore welts that never seemed to go way. 

What other choice did he have? Remember...all or nothing! 

It was then that the first pill for people with MS was released...TRIUMPH! He has been on it ever since, and has done very well! And this is all thanks to research...which brings me to my conclusion: please donate to our Walk MS Boise team to help raise money for research so more therapies may one day be available!"

Of course, the funds we are raising for Bike MS contributes to the same research that helped provide new therapies for Chris.

Thanks for sharing that, Megan! Look for more "other voices" stories over the coming weeks...

This concludes the 144th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on July 11, 2013. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, July 9, 2013.

Comments for this post.

Two-year Update on MS Society-Funded CCSVI Projects

The National MS Society has released a two-year progress report on the seven society-funded CCSVI research studies in MS.  While some researchers have presented preliminary findings at the ECTRIMS conference in October 2011 and the AAN conference in April 2012, most researchers are still in the process of completing their projects.

Updates for each of the seven projects (as of January 2012) are available on the NMSS website.  Click on the title of the research project to open up a more detailed description of the project and preliminary results, including links to abstracts presented at ECTRIMS by Drs. Fox and Wolinsky.  Details of the posters presented at AAN by Drs. Fox and Wolinsky are included in the Society’s news bulletin of May 16, 2012.

One team of society-funded researchers from Calgary has published a paper based on the cases of five people who had experienced medical complications after undergoing CCSVI venoplasty procedures: “Complications in MS Patients after CCSVI Procedures Abroad.” Burton JM, Alikhani K, Goyal M, Costello F, White C, Patry D, Bell R, Hill M. (Calgary, AB) Can J Neurol Sci 2011 Sep;38(5):741-6. 

For information regarding other CCSVI-related studies, the CCSVI Alliance maintains a searchable database of published articles.

National MS Society Press Release (May 4, 2012):

Researchers Continue With Their Progress in the Seven Society-Funded CCSVI Studies in MS

Seven research projects investigating CCSVI (Chronic Cerebrospinal Venous Insufficiency) and MS -- launched with a $2.4 million investment by the National MS Society and the MS Society of Canada -- have reached the two-year milepost.

The funded multi-disciplined researchers have been reporting significant progress in their two-year study goals. As of July 2012, most of the investigators are in the process of completing their projects and expect to do so within the next year. Although the work continues for several of the teams, some are already presenting preliminary results at medical meetings, and all have shared technical advice so that the projects can move forward as smoothly and quickly as possible.

The need for continued work beyond the two-year grant funding period is not uncommon, as practical and logistical issues begin impacting on projected timelines, including such items as:

• getting proper protocols in place;
• applying for and gaining approvals from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a requirement established by regulatory authorities to protect humans involved in research projects;
• getting technicians and other team members trained on how to conduct appropriate screenings; and
• recruiting study participants.

After the research projects are completed, the data collected in these studies will be analyzed and submitted for publication in one or more scientific journals so that other scientists can evaluate and comment on the findings. Currently it is not known when the full data and results will be available, though updates will continue as appropriate to reflect the ongoing transparency of the work being supported by the U.S and Canadian MS Societies. Results from the seven projects, as well as other studies underway around the globe, will help guide our planning for future investments in this area of research.

Research project highlights and progress

• The teams include an integration of experts drawn from all key relevant disciplines including neuroradiology, neurovascular imaging, MS imaging, vascular surgery, biostatistics, interventional radiology, interventional neuroradiology and MS clinical neurology. Bringing together experts across these areas will help to facilitate understanding of CCSVI in MS as quickly as possible.
• The research teams have recruited and scanned a broad spectrum of people with MS and others to build understanding of who may be affected by CCSVI. In addition they are refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process. 
• Already more than 900 people have undergone scanning with various imaging technologies being used by the studies, including the Doppler ultrasound technology used by Dr. Paolo Zamboni and his collaborators, as well as magnetic resonance studies of the veins (MR venography), catheter venography, MRI scans of the brain, and clinical measures.

Some of the teams have been trained in, and are using, the ultrasound technique originally published by Dr. Zamboni. Others are using the same methods but are utilizing standard Doppler ultrasound machines rather than purchasing the specific machine used by Dr. Zamboni’s team. 

Future Steps – Clinical Trial and Live Webcast PlannedGrantee results will help guide future steps, including the development of a clinical trial to test whether treating vein blockages is a safe and effective therapy for people with MS. The Canadian Institutes of Health Research (CIHR) announced in April 2012 that a research team had been chosen to conduct a phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. The location of the study has not yet been announced.  The clinical trial is a collaborative initiative between the CIHR and the MS Society of Canada.

At this point, no connection has been confirmed between CCSVI and MS, in fact, CCSVI appears to occur in many people who do not have MS. Although some individuals who have MS have undergone surgical procedures for CCSVI, there has not yet been a controlled trial to determine its effectiveness in treating the symptoms or course of the disease. In addition, the U.S. FDA has issued a safety communication about potential risks associated with procedures and devices used to treat CCSVI, encouraging additional research.

The National MS Society shares in the public urgency to advance the understanding of CCSVI as quickly as possible, and is urging researchers to complete their studies and to analyze and publish their results as soon as possible. The Society plans to host a live Webcast in the spring of 2013 as a forum for a discussion about the progress made in the understanding of CCSVI and MS. 

For those who may not want to wait for research results in order to get tested for CCSVI and/or who want to undergo surgical treatment now, this is a personal decision to be discussed with their healthcare providers. To get the most reliable results about benefits and risks of any surgical procedure that might attempt to address blood flow in or out of the brain, as well as to further the overall understanding of CCSVI and how it may affect people diagnosed with MS, it is important that such surgery be performed as part of controlled trials, especially in light of adverse events reported to date.

Positive Psychology, Multiple Sclerosis, and Everyday Matters

“The study of positive psychology [is] a growing interest in using science to understand more about human strength and resilience regardless of specific circumstances.” - Everyday Matters information sheet

No matter what your challenges may be, the ability to be resilient carries you forward in life.  The power of positive thinking - a phrase made popular by the Norman Vincent Peale publication of the same name in 1996 - is a philosophy which focuses on positive growth and the achievement of one’s highest potential.  The scientific study of positive psychology has blossomed since the 1985 publication of the groundbreaking work of Michael F Scheier and Charles S. Carver in the seminal study, "Optimism, Coping, and Health: Assessment and Implications of Generalized Outcome Expectancies" in Health Psychology. 

The National MS Society has teamed up with Sanofi-Genzyme (developers of Teriflunomide and Alemtuzumab) to present Everyday Matters (everydayMSmatters.org), a program which aims to engage and inspire the MS community.  This new program will teach positive psychology by teaming renowned psychology expert and former Harvard University lecturer Shawn Achor with Kristen Adams, a mom and Emmy‐award winning producer living with MS, and Michelle Clos, a life coach certified by the International Coach Federation who is also living with MS.

Throughout the course of the Everyday Matters program, Shawn, Kristen and Michelle will work hand‐in‐hand with five individuals affected by MS from across the country as they map out strategies for achieving a specific goal or addressing a specific challenge in their everyday life.

How do you become one of the lucky FIVE to work with Shawn, Kristen and Michelle?

Beginning now through June 13, 2012, interested individuals can visit everydayMSmatters.org to submit their stories for consideration by the Everyday Matters team, or vote on the challenge, topic or goal that is most important to them.

Participants are asked to share a particular “everyday” challenge they would like to overcome or a goal they want to achieve.  Stories can be shared through video or text and photos. All story submissions will be eligible for consideration for a personal coaching opportunity with the Everyday Matters team.

Five participants, each representing a different challenge or goal, will be selected to attend a weekend workshop with the team in Denver, Colorado from July 13 – 15, 2012, and will receive six months of personal coaching from Michelle. Each participant’s journey will come to life through a video series produced by Kristen and showcased on the website.

The most important criteria for participant selection will be the interest shown by people in the MS community, who are invited to go to the site and vote on the topics, issues and challenges that are most important to them in their own lives. As the title implies, this program is about facing the “everyday matters” of life with MS and sharing what you have learned with the entire MS community.

I will be talking with Kristen next week regarding the everydayMSmatters.org program.  if you have any specific questions you’d like me to ask, please leave them in the comment section below.

But don’t wait!!  Submit your stories, videos, or photos for consideration as the deadline quickly approaches.  Then as part of the MS community, be sure to vote on the topics which interest you the most.

My Day on Capitol Hill: An MS Activist in Action

Wednesday was the big day! MS activists from around the country visited countless offices on Capitol Hill to voice their support of specific legislative issues needed to improve the lives of people affected by multiple sclerosis. Requests made to lawmakers this year on behalf of people with MS nationwide included:

• Support the Lifespan Respite Care Program: 
• reauthorize the program by passing H.R. 3266 and 
• include $5 million in the FY2013 Labor-HHS-Education appropriations bill for the program.
• Support MS Research: 
• provide $32 billion in FY2013 for National Institutes of Health and
• sign Dear Colleague Letter or make programmatic request for additional appropriations (money) for the MS Research Program (MSRP) under the Congressionally Directed Medical Research Program. Last year the MSRP received $3.8 million.
• Join the Congressional MS Caucus: contact MS Caucus co-chairs Representatives Michael Burgess, MD (TX-26) and Russ Carnahan (MO-3) and Senators Robert Casey (PA) and Orrin Hatch (UT).
• Support MS Awareness Week Resolution: 
• co-sponsor the MS Awareness Week Resolution (H. Res. 560) and
• contact Representative Barbara Lee (CA-9) and Senator Bob Casey (PA) to voice your support.

Todd Adams, Legislative Director to U.S. Representative James R. Langevin (RI-2) and the Society’s 2011 Congressional Staffer of the Year, made the following suggestions in preparation for our visits:

• Regardless of whom you meet in the office, establish a connection. Tell them your story.
• Make it known if you are a constituent.
• Clearly present your “ask.” What do you want the congressman to do or support? Explain what it will mean down the road to you and others. Leave behind materials detailing your request.
• Be mindful of time.
• Exchange information so that the office can contact you.
• FOLLOW UP!! Possible questions to ask: “Did you have an opportunity to look over our priorities? Did you have any questions? Did your boss sign off on our request? Was he OK with it?”
• Most importantly, HAVE FUN!!

My day began as MS activists from Virginia loaded the first bus leaving the hotel. Dropped off in front of the Capitol Building, I went with Dana and Phil, fellow MS activists, to visit the office of James Moran (VA-8), our U.S. Representative. We met with Moran’s Legislative Assistant, Marcia Knutson. Tip: Allow at least one hour to enter the office buildings in the morning. 

Dana and Phil have an ongoing relationship with Ms. Knutson, and Rep. James Moran is generally supportive of healthcare issues, so not much time was spent discussing the requests. Knutson wanted to know the bill numbers and specific dollar amounts being requested, as she wrote in her notebook. From there, the conversation traveled between various topics and I picked up on a few additional details which may be important to keep in mind when contacting your own lawmaker’s office.

• Although email communication is increasingly becoming more common, take the time to visit the office. An in-person visit to educate the Legislative Assistant on an issue, especially one with which he/she is unfamiliar, is highly preferable.
• If you send a blanket form letter to 300+ offices, most of which do not house your personal representative or senator, don’t expect it to be taken as seriously.
• Don’t just ask for “more money” in your request. Be prepared with specific dollar amounts.
• Know your lawmaker’s deadlines for Budget Hearings. Rep. Moran’s deadline for submitting materials in preparation for a March 28th or 29th hearing is March 20. As the legislative assistant must prepare materials in advance of this deadline, groups meeting with Ms. Knutson with budget requests after March 13 will be left out of consideration.
• Unfortunately, if you choose to send a letter to your Senator or Representative, it will face up to a 6-week delay because of the rigorous security screening process in place – email is preferable. And if you don’t hear back from the office after an email, call to be sure they received it – Spam filters in Congress sometimes divert email messages.

Before we left Rep. Moran’s office, I was able to jump into the conversation and express my personal concerns as a self-employed person who has an individual health insurance policy. As a “grandfathered” policy, it does not need to match the same requirements incorporated into new policies being offered by the same company. Ultimately I was asked if I could hold out until 2014 when health exchanges will be established in our area. I’m not positive that my concerns were entirely understood, which means that I need to follow up and continue the conversation. 

After going through this, I realized how easy it really was. A visit to a lawmaker’s office is just the beginning of a longer conversation. What you do afterward will determine how well your voice is heard and your concerns are understood. Each phone call is documented and emails are read. Every contact is important. Now is the time to keep MS-related issues at the frontline of Capitol Hill. 

Help keep the momentum going – follow the federal advocacy efforts on twitter at @MSActivist and after you’ve contacted your elected official or take some other action, tweet about it using hashtag #MSActivist.

Originally published on National MS Society blog.

Interviews with Inspiring MS Advocates at NMSS Conference

Before the National MS Society Public Policy Conference was complete, I had an opportunity to interview more inspiring MS activists.  You can read their stories:

From the Sea to Capitol Hill: An Interview with MS Activist Donnie Horner

In his first two years stationed in San Diego, Donnie spent about 300 days at sea. His job required him to spend many hours on his feet. “When I was out to sea, I began to develop tingling in my legs in July and August 2009. Because I had spent so much time out to sea, I said to myself, ‘Man, this just must be sea legs or something like that.’ When we got back into port, I noticed my symptoms started to get worse. I went to a couple of my buddies and they said, ‘You really need to go see a doctor.’ So I did.”

Donnie described his legs as feeling weak and heavy, with the sensation of falling asleep. He would try to hit his legs in an attempt to wake them up. “My mind was going, but my legs weren’t able. And it hurt, the constant pressure of standing on the needles.” Coincidentally, Donnie had never experienced these symptoms until after he received required vaccinations – anthrax, tuberculosis, tetanus – in May/June 2009. “I’m not kidding. I received a dozen vaccinations the summer I was diagnosed.”

Increase Funding for MS Research: An Interview with Sarah Keitt

“I have been involved with the MS society since 2000 when I was first diagnosed. I’ve volunteered in one way or another. I have a background in public health and worked on clinical research issues [in my career], so I have a strong familiarity with study design, clinical research, and bioethics. Then an opportunity came up that fit my professional interests along with my personal interest in MS.”

“If you don’t get involved with advocacy, no one else is going to do it for you. It’s up to us, as people with MS, to make sure that the funding for research is there, that services for people with MS and other disabilities are there. It’s really critical that we get involved in any way that we can!”

Thanks to Donnie and Sarah for sharing their stories and becoming advocates for people living with MS nationwide.  I met so many wonderful individuals during the Conference that I wish it were possible to share all of their stories.  We have so many in the MS community who are tireless leaders and wonderful advocates.

Highlights from MS Public Policy Conference

Day One of the conference sped by so very quickly. Read about the opening afternoon sessions in my post - Washington from the Inside: The Political Climate and Multiple Sclerosis. Day Two is not yet complete, but you can catch up on a very important issue, the Lifespan Respite Care Act, in today's post - Family Caregivers, MS Research, and MS Champions. In just a few minutes, I'll head back down to the Ballroom to kick back and enjoy the comedy stylings of Brett Leake, a standup comic turned sit-down comic who lives with muscular dystrophy. My interviews with two inspiring MS activists will be posted tomorrow while we are all headed to The Hill.

All the Little Voices

Lee Domenico, Lisa Emrich, Ted Thompson

Day One of the 21st Annual National MS Society Public Policy Conference has come to a close.  Lots of excitement as MS Activists from across the country have landed in DC.

I attended the opening sessions this afternoon and met up with Lee Domenico from Delaware.  Lee shared her story with me earlier and you can read her interview at All the Little Voices Working Together.

As more blog posts go up on the National MS Society's blog, I will let you know.  Tomorrow begins bright and early at 7:30am.  Until then, good night.

Blogging from DC

I'll be blogging from the 21st Annual National MS Society Public Policy Conference in Washington, D.C.  I've been studying the agenda and am really exciting to be learning more about MS Research, the Caregiving and Lifespan Respite Act, and updates in healthcare reform which affect MS patients.

Read more at:

Demystifying Public Policy: MS Activists on the Frontline


In case you were thinking to yourself - Doesn't Lisa live near DC?
Yes, I do. However in the 13+ years I've lived here, I have not once visited my Representative's DC office downtown.  This will be a new experience.  Very excited!

Multiple Sclerosis Advocacy on Capitol Hill

What does Advocacy and Activism mean to you?

MS Activists on the Frontline

In looking at the agenda of the 21st Annual National MS Society Public Policy Conference in Washington, D.C., the fiscal budget is one area in which MS Activist will take their voices to Capitol Hill to advocate, or lobby, for continued funding or increased funding for MS research.  Activists will also urge lawmakers to reauthorize programs which aim to assist MS patients and their families, such as the Lifespan Respite Care Act.

I am looking forward to learning more about the recent victories the National MS Society, together with other patient advocacy organizations, have won in recent years.  I am also eager to gain a better understanding of the lobbying process as I aim to demystify public policy. 

While I’m at the conference, is there anything specific that you would like to read about? 

One thing which is on my agenda is to bring you the information you need to become an MS advocate/activist from your own home.  Letters, emails, and phone calls to legislators really do make a difference.

Read this post in its entirety:

MS Advocacy and Public Policy on Capitol Hill

National MS Society Provides 18-Month Update on Society-sponsored CCSVI Research

As CCSVI Research progress is of interest to many MS patients in our online community, I wanted to make sure that the following information was made available quickly.  Here is an update provided by the National MS Society of the seven research projects which received grants almost two years ago. 

It is interesting to note that the preliminary results of these studies combined reveal how variable "CCSVI testing results can be depending on a host of outside issues such as water intake,  or whether the individual being tested is breathing in or breathing out.  These are all issues that will need to be addressed -- especially during proposed clinical trials -- if researchers are going to be able to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process."

For more information on Cerebrospinal Venous Insufficiency, I recommend that you visit CCSVI.org.

Research Teams Report on 18 Months of Progress from MS Societies’ Initial Studies on CCSVI and MS
New York, NY, 1/27/12..Reports from seven multi-disciplinary teams investigating CCSVI (chronic cerebrospinal venous insufficiency) in MS (http://www.nationalmssociety.org/ccsvi) indicate that they are making good progress toward providing essential data and critical analysis as these two-year projects move toward their completion. The studies were launched on July 1, 2010 with a more than $ 2.4 million commitment from the MS Society of Canada and the National MS Society (USA). The ongoing work by the seven teams will help inform the design of an early-phase clinical trial that is expected to launch in late spring 2012 with funding from the MS Society of Canada and the Canadian Institutes of Health Research (CIHR).

The research teams have recruited and scanned a broad spectrum of people with MS and others to build understanding of who may be affected by CCSVI. In addition they are refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process. All of the seven teams are working under approvals from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a first step established by regulatory authorities to protect human subjects involved in research projects. (Read more about steps involved in conducting clinical research.)

Already more than 800 people have undergone scanning with various imaging technologies being used by the studies, including the Doppler ultrasound technology used by Dr. Paolo Zamboni and his collaborators, as well as magnetic resonance studies of the veins (MR venography), catheter venography, MRI scans of the brain, and clinical measures.

Representatives of each of the seven funded teams are part of the CIHR’s Scientific Expert Working Group. In November 2011 the Canadian Institutes of Health Research (CIHR) announced the release of a Request for Proposals seeking grant applications from researchers to conduct an early-phase clinical trial in Canada to test the ability of a surgical procedure called balloon venoplasty to improve blood drainage in individuals with MS who have been identified as having CCSVI. The request for research proposals is a collaborative initiative between the CIHR and the MS Society of Canada. The working group will provide leadership and advice concerning the clinical trial, and will continue to monitor and analyze the data from the seven studies and other studies related to CCSVI and MS around the world.

Several teams have presented, or are planning to present, preliminary results at  medical meetings. Because the studies employ rigorous blinding and controls designed to collect objective and comprehensive data, the full results of the ongoing research will be available only after completion of the studies which will involve more than 1300 people representing a spectrum of MS types, severities and durations, as well as individuals with other disease types and healthy controls.

“The research underway is significantly advancing our understanding of CCSVI and what its relationship might be to MS disease process,” notes Dr. Tim Coetzee, chief research officer at the National MS Society. Dr. Karen Lee, Vice President Research at the Canada MS Society, concurs, “We are pleased that our collaborations with the National MS Society and CIHR are moving us closer to the answers that people with MS need about CCSVI and MS.”

Details of ProgressThe funded investigators, who are drawn from a broad range of disciplines ranging from MS neurology, vascular surgery and interventional radiology, report progress in establishing standardized protocols, recruiting and scanning participants and in the development of plans for sharing their findings, as summarized below. 

Dr. Brenda Banwell, The Hospital for Sick Children, Toronto, Ontario:Dr. Banwell’s team is seeking confirmation for findings that Cerebrospinal Venous Insufficiency is a cause for Multiple Sclerosis (MS). If impaired venous drainage occurs as a key part of the beginnings of the MS process, then venous abnormalities should be present even in the youngest MS patients. The team is now studying children and teenagers with MS to determine whether the venous system is abnormal in a population where the disease process is at a very early stage. Unlike adult MS patients, children are very unlikely to have any age-related changes in blood vessels, and do not have any of the adult-onset health conditions (such as high blood pressure, heart disease, use of medications) that might complicate the ability to determine whether blood flow patterns are due to MS or other causes. Their ultrasound team has received training from Dr. Zivadinov’s group in Buffalo, and has created ultrasound and brain imaging procedures suited to explore venous drainage in children. They plan to assess 30 children with MS, 30 healthy children of the same age, and 30 “graduates” (young adults who experienced the onset of MS during childhood and who received care and prior brain imaging studies at the Hospital for Sick Children). Enrollment began in December 2010 and Dr. Banwell’s team has reported that it is going well. To ensure the highest standards of scientific accuracy, they intend to analyze their findings once all 90 participants have undergone the testing; which will help to determine whether impaired venous drainage is indeed a core component of MS.  (Read details of Dr. Banwell’s original study plans.)

Dr. Fiona Costello, Hotchkiss Brain Institute, University of Calgary, Calgary, AlbertaThe University of Calgary team has initiated a prospective cross-sectional study to determine the association between ultrasonography (US) and magnetic resonance venography (MRV) measures of venous outflow in MS patients. This study will evaluate 120 people with MS (including 65 with relapsing-remitting MS, 20 with secondary-progressive MS, 10 with primary-progressive MS, 10 with neuromyelitis optica, and 15 with pediatric MS) and 60 age- and sex-matched healthy control subjects. To date, 98 participants have been recruited. The main outcome measure will be the proportion of cases and controls with US and MRV evidence of extracranial venous outflow obstruction. Secondary outcomes will include MRI measures of brain inflammation, Expanded Disability Status Scale (EDSS) scores, and extracranial US measures of venous wall thickening and jugular valve competence.

The team published a paper based on the cases of five people who had experienced medical complications after undergoing procedures focused on treatment of venous abnormalities: “Complications in MS Patients after CCSVI Procedures Abroad.” Burton JM, Alikhani K, Goyal M, Costello F, White C, Patry D, Bell R, Hill M.  (Calgary, AB) Can J Neurol Sci 2011 Sep;38(5):741-6.  (Read details of this team’s original study plans.)

Dr. Aaron Field, University of Wisconsin School of Medicine and Public Health, Madison: Official approval of this study protocol was issued on June 28, 2011. The team continues to actively recruit study subjects from a database of approximately 100 MS patients who had contacted them since the study was first announced, as well as from the patient population seen regularly in their MS clinic. Thus far, 17 people with MS and 12 healthy controls have undergone both MRI/MRV and ultrasound imaging. No results are yet available as the study is blinded.

Since the previous progress report, Dr. Field was awarded a $27,000 grant from his institution to further investigate the novel MRI components of this study in healthy controls, particularly with regard to reliability and reproducibility. Specifically, they investigated (1) the use of a novel method to adjust venous flow measurements for variations related to breathing and heartbeat, (2) the use of a novel MRI method for measuring the iron content in brain tissue, and (3) the use of a relatively new, FDA-approved MRI contrast agent (a drug administered intravenously to enhance the visibility of blood vessels on MRI) that can enhance the visibility of head/neck veins and enable the measurement of blood flow through brain tissue. Ten healthy subjects underwent these components of the team’s CCSVI protocol twice, on separate days. Progress made in these studies includes:

• The team’s novel approach to measuring venous flow with MRI is able to detect clear differences in venous flow between inspiration and expiration, and demonstrates evidence of expiration-related reflux (backwards flow) in the jugular veins of healthy subjects.
• The team’s system of rating the degree of venous narrowing on MR images of the azygous and jugular veins yields comparable results when performed by different individuals. 
• Their novel MRI method for measuring iron content in brain tissue provides reproducible results that are comparable to previously described methods of iron measurement, with fewer technical pitfalls.
• A single dose of a relatively new MRI contrast agent is sufficient to enhance the visibility of head/neck veins and generate reproducible maps of blood flow through the brain. (It would normally require two separate doses of a conventional contrast agent to accomplish both of these objectives.)

These investigations have yielded two abstracts presented or to be presented at national/international imaging meetings:

“Comprehensive assessment of cerebral venous return with MRA: preliminary results.” Wieben O, Johnson K, Schrauben E, Reeder S, Field A. 23rd annual meeting of the “MRA Club” (International Magnetic Resonance Angiography Workshop), Calgary, Alberta, Canada, September 25-28, 2011.

“The importance of the sonographer in the investigation of chronic cerebrospinal venous insufficiency.” Kohn S, Kliewer K, Field AS. American Institute of Ultrasound in Medicine (AIUM) Annual Convention, Phoenix, AZ, March 29-April 1, 2012.

In addition, three abstracts have been submitted for consideration for the American Society of Neuroradiology (ASNR) 50th Annual Meeting, New York, NY, April 21-26, 2012, and two have been submitted for the International Society of Magnetic Resonance in Medicine (ISMRM) 20th Annual Meeting & Exhibition, Melbourne, Victoria, Australia, May 5-11, 2012.  (Read details of Dr. Field’s original study plans.)

Dr. Robert Fox, Cleveland Clinic Foundation, Cleveland: Dr. Fox’s team continues to use MR venography, ultrasound, MRI and clinical measures in people with MS or who are at risk for MS (CIS) and comparison groups to evaluate vein drainage. The ultrasound team, which underwent training in the technique originally used by Dr. Zamboni, found several aspects of the published methodology ambiguous, and they have standardized the protocol and analysis to achieve consistent results.

Early on they identified physiological and technical factors that can complicate screening for vein blockages using ultrasound, including that heartbeat irregularities, stages of breathing, head position and pressure applied by the operator could alter results; and that the state of hydration of the subject (whether they drank adequate amounts of fluids) might impact results of several of the criteria used to determine CCSVI.

The team reported at the international ECTRIMS/ACTRIMS congress in October 2011 preliminary results of ultrasound assessments. Pooling the results of the ongoing, blinded study of CCSVI in MS and non-MS controls, they reported results from the first 20 subjects, finding that 6 (30%) met criteria for CCSVI, four subjects met no criteria, and none met criteria for reverted postural control of cerebral venous outflow. Nine subjects (45%) had a flap and/or septum/abnormal valve. Identification of deep cerebral vein reflux depended upon the ultrasound technique. They noted that this finding highlights the importance of ultrasound methodology in performing and interpreting deep cerebral vein assessments. (P1104 – “Ultrasound assessment of chronic cerebrospinal venous insufficiency.” R. Fox, L. Baus, C. Diaconu, A. Grattan, I. Katzan, S. Kim, M. Lu, L. Raber, A. Rae-Grant)

At the same ECTRIMS/ACTRIMS meeting, the team shared preliminary results from an ongoing study of vein structure in autopsy specimens from seven people who had MS in their lifetimes, compared to six people who did not have MS. In this unblinded study, they identified abnormalities inside the vein tubes (lumen) that drain the brain and found a variety of structural abnormalities and anatomic variations in both groups. However, they reported higher frequency of abnormalities in those who had MS (2 abnormalities in 2 out of 6 controls versus 9 abnormalities in 6 out of 7 MS patients). They noted that MR venography may be less effective than ultrasound for identifying these venous abnormalities, and that ultrasound that examines only vein wall circumference may miss some intraluminal abnormalities. (Abstract 134 – “Anatomical and histological analysis of venous structures associated with chronic cerebro-spinal venous insufficiency.” C. Diaconu, S. Staugaitis, J. McBride, C. Schwanger, A. Rae-Grant, R. Fox)  (Read details of this team’s original study plans.)

Dr. Carlos Torres, The Ottawa Hospital, University of Ottawa, Ontario:The team began phase 1 of their project which consists of imaging with MRI the veins of the head and neck of 100 people without MS. MR venography is also being performed to obtain normative data that will allow the team to better understand the normal anatomy and variants of the veins before they begin to examine the veins of the subjects and controls. 

So far, they have performed this additional sequence in 85 people and expect to complete the target of 100 within the next 2 weeks. Further, they have gathered MRI studies of 30 people with a specific sequence that allows them to measure the amount of iron in the brain. The iron deposits are being quantified by an MR Physicist.

In order to perform the ultrasound studies of the veins in the head and neck the same way they were done as described by Dr. Zamboni, the team received training in Vancouver from an experienced group who received training in Italy. Two sonographers and a radiologist traveled to Vancouver and received appropriate training on the technique in mid-May.

In early September, the team reported that they successfully started phase 2 of the study recruiting subjects and controls through the Ottawa Hospital MS Research Unit. Since then, they have recruited a total of 30 people with MS (with relapsing-remitting, primary-progressive or secondary-progressive MS) and 30 controls (60 total), who have undergone both a contrast enhanced MRI and an ultrasound of the veins of the head and neck. The team is currently scanning approximately 4 people with MS and 4 controls per week. They expect to complete recruitment and begin analysis of the data by mid February 2012.  (Read details of this team’s original study plans.)

Dr. Anthony Traboulsee, UBC Hospital MS Clinic, UBC Faculty of Medicine and Dr. Katherine Knox, Saskatoon MS Clinic, University of Saskatchewan:
This team is conducting their study at two centers (UBC Hospital, Vancouver, BC and Saskatoon City Hospital, Saskatoon, Sask.) and the goal is to recruit up to 200 subjects. Imaging protocols have been both developed and tested and the group is very satisfied with the quality of their results. Their ultrasound technologists were trained by Dr. Zamboni to perform the ultrasound testing in a similar way. There is no previous standardized venography protocol for looking at neck veins.

Recruitment is now closed at the University of British Columbia site, and will be closing soon at the Saskatoon site. All investigations are expected to be completed in March 2012. The team plans to do the preliminary analysis by April 2012. Analysis will occur in stages, starting with the catheter venography and ultrasound data, then the MR venography results will be reviewed.

The team reported that the level of interest and response rate remained high throughout recruitment. The UBC site recruited 110. At the Saskatoon site, 70 subjects have been recruited and are at various stages of the protocol. All investigators remain blinded to the status of the subjects and do not have any preliminary results to report at this time.  (Read details of their original study plans.)

Dr. Jerry Wolinsky, University of Texas Health Science Center at Houston: The team reports that they have recruited about 82% of the expected study cohort. The cumulative number of volunteers recruited from study inception includes: 10 Healthy Volunteers; 34 Other Neurological Diseases; 22 Stroke/TIA; 12 CIS; 112 relapsing-remitting MS; 44 secondary-progressive MS; 1 progressive-relapsing MS; 15 primary-progressive MS. Of people with MS or CIS, 45 have undergone MR venography with advance MRI. In addition, to date 10 people with MS have consented to transluminal venography, 2 are scheduled for study and 4 have completed the procedure without complications. No therapeutic interventions are considered in these investigations.

Dr. Wolinsky and the team’s MR vascular expert, Dr. Larry Kramer, are members of the MS Scientific Expert Working Group established by the Canadian Institutes of Health Research (CIHR), in collaboration with the Multiple Sclerosis (MS) Society of Canada, and additional team members have participated in the meetings and provided advice to the CIHR as requested.

A summary of the team’s preliminary work was presented as a poster at the international ECTRIMS/ACTRIMS congress in October 2011. They used Doppler technology to evaluate venous drainage in a blinded fashion. They reported that of all participants, 48/162 fulfilled at least one of five criteria for anomalous venous outflow proposed by Dr. Zamboni; 10/48 fulfilled two criteria consistent with CCSVI; none fulfilled more than 2 criteria. There was no significant difference between people with MS and non-MS, or within MS subgroups. They also found no significant differences between MS and non-MS subjects for measures of cross-sectional areas of the internal jugular veins or for venous flow rates. The team concluded that thus far they find less CCSVI than previously reported by other groups. They are now focusing on whether ultrasound can be complemented or supplanted by MRV and/or transluminal venography. (P1108 -- “Prospective, case‐control study of CCSVI with imaging‐blinded assessment: progress report focused on neurosonography.” Barreto AD, Brod SA, Bui T, Jamelka J, Kramer LA, Ton K, Cohen AM, Lindsey JW, Nelson F, Narayana PA, Wolinsky JS (2011). MSJ 17(S10):S511‐2.)

In addition, two abstracts have been submitted for consideration for the 64th Annual Meeting of the American Academy of Neurology to be held in late April 2012.  (Read details of this team’s original study plans.)

Going ForwardThese seven teams were chosen by an international panel of experts that included specialists drawn from all key relevant disciplines including radiology, vascular surgery and neurology. The projects were selected for having the greatest potential to quickly and comprehensively determine the significance of CCSVI in the MS disease process. (Read more http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=3339)

At this 18-month milepost, the investigators are making significant progress on their overall two-year study goals. Some of the teams are presenting preliminary results at medical meetings, and all have shared technical advice so that the projects can move forward as smoothly and quickly as possible. Their results will help guide the development of an early-phase clinical trial to test whether treating vein blockages may be safe and effective in treating people with MS. The trial should launch in late spring 2012 with funding from the MS Society of Canada and the Canadian Institutes of Health Research (CIHR).

The next update on the work of the seven grantees will be reported in six months.

About the National Multiple Sclerosis SocietyThe National MS Society addresses the challenges of each person affected by MS. To fulfill this mission, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, collaborates with MS organizations around the world, and provides programs and services designed to help people with MS and their families move forward with their lives.  In 2010 alone, through its national office and 50-state network of chapters, the Society devoted $159 million to programs and services that assisted more than one million people. To move us closer to a world free of MS, the Society also invested nearly $40 million to support 325 new and ongoing research projects around the world. The Society is dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.

About Multiple Sclerosis Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Every hour in the United States, someone is newly diagnosed with the disease. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 400,000 people in the U.S. and over 2.1 million worldwide.

Contact:  Arney Rosenblat / 212 476-0436
   Arney.rosenblat@nmss.org
  

National MS Society Launches a Blog!

Coordinated with coverage from ECTRIMS, the National MS Society has launched a blog.  This is the first phase of expansion of their online community in the coming year.

ECTRIMS/ACTRIMS (The Congress of the European and Americas Committee for Treatment & Research in MS) is occurring in Amsterdam during October 19-22, 2011.  In attendance at the conference is "the largest collection of MS researchers in the world, with more than 7,000 scientists and clinicians from around the globe, meeting and presenting on cutting edge and breaking MS research news."

Watch for live updates brought to you by Julie Stachowiak and Kate Milliken (working with NMSS), as well as tweets and video from Ashley Ringstaff at MS World (@Ashtabulous).

Let's all welcome NMSS to the MS Blogging Community.

The MS Blogging Community has grown from about 100 blogs four years ago to over 600 MS blogs written by patients, family members, caregivers, and organizations.  The community continues to grow with more than 300 blogs currently active.

Visit the MS Blogging Community page for its real-time feed of new posts published by the bloggers who are listed.  I'm sure that I do not have every MS blog included on this page yet.  Please contact me if you are not listed.

Don't forget to subscribe to the Carnival of MS Bloggers, and please follow Brass and Ivory.

Update in CCSVI Studies and Retirement of NMSS CEO Joyce Nelson

The National Multiple Sclerosis Society (USA) has announced the one-year progress reports for the 7 grants which were funded to study CCSVI and MS. The news release is published below.

Also, a NICE committee met today to discuss CCSVI treatment. And Marc Stecker continues to keep us updated in all areas CCSVI related including a Roundtable Video and this weekend's CCSVI Symposium in NYC.

When perusing the bi-weekly "Insider's Perspective" of the Society's Plans (pdf), I noticed that an article in the upcoming Momentum Magazine will detail the retirement of Joyce Nelson, current President and CEO of the National MS Society. I'm interested to see what are the Society's next moves in leadership.

Research Teams Report First Year’s Progress From MS Societies’ Initial Studies on CCSVI and MS

Jul 14, 2011
The first-year progress reports from seven multi-disciplinary teams investigating CCSVI (chronic cerebrospinal venous insufficiency) in MS indicate that they are on track to provide essential data and critical analysis as these two-year projects move toward their completion. These studies were launched on July 1, 2010 with a more than $ 2.4 million commitment from the MS Society of Canada and the National MS Society (USA).

The research teams have already recruited a broad spectrum of people with MS and others to build understanding of who may be affected by CCSVI. In addition they are refining CCSVI imaging methods for accuracy and consistency in order to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process.

Representatives of each of the seven funded teams are part of the Canadian Institutes of Health Research (CIHR)’s Scientific Expert Working Group. Following a meeting of the working group in June 2011, the Canadian Federal Minister of Health, the Honourable Leona Aglukkaq, announced a Phase I/II interventional clinical trial on CCSVI. The working group will provide leadership and advice in the drafting of the terms of reference for the Phase I/II clinical trials in Canada, and will continue to monitor and analyze the data from the seven studies and other studies related to CCSVI and MS around the world.

Regarding the seven funded teams, all have received approval for their studies from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a first step established by regulatory authorities to protect human subjects involved in research projects. (Read more about steps involved in conducting clinical research.)

Already more than 486 people have undergone scanning with various imaging technologies being used by the studies, including the Doppler ultrasound technology originally used by Dr. Paolo Zamboni and his collaborators, as well as magnetic resonance studies of the veins (MR venography), catheter venography, MRI scans of the brain, and clinical measures.

Because the studies employ rigorous blinding and controls designed to collect objective and comprehensive data, the full results of the ongoing research will be available only after completion of the studies which will involve more than 1300 people representing a spectrum of MS types, severities and durations, as well as individuals with other disease types and healthy controls. In the meantime, several teams are planning to present preliminary results at medical meetings later this year.

“We are pleased that this important work investigating the link between CCSVI and MS is advancing quickly,” notes Dr. Tim Coetzee, chief research officer at the National MS Society. “Results from these comprehensive studies will help inform important next steps.”

Yves Savoie, President and chief executive officer of the MS Society of Canada concurs, “The CIHR’s Scientific Expert Working Group, who will provide leadership and advice in the drafting of the terms of reference for the Phase I/II clinical trials in Canada, will continue to monitor and analyze the data from these studies and other studies related to CCSVI and MS around the world. We are heartened to be moving closer to more definitive answers about CCSVI and MS.”

Details: The funded investigators, who are drawn from a broad range of disciplines ranging from MS neurology, vascular surgery and interventional radiology, report progress in establishing standardized protocols, recruiting and scanning participants and in the development of plans for sharing their findings, as summarized below.

• Dr. Brenda Banwell, The Hospital for Sick Children, Toronto, Ontario:
To determine whether signs of impaired vein drainage might be present early in the MS disease course, Dr. Banwell’s team received approval from the Research Ethics Board and then began enrolling children and teenagers who have MS, and healthy controls of the same age. They are seeking venous abnormalities using non-invasive MRI measures of vein anatomy and novel measures of venous flow, as well as ultrasound. Unlike adults with MS, children are unlikely to have age-related changes in blood vessels, and are less likely to have adult health conditions such as high blood pressure or heart disease, which might otherwise complicate findings. The team’s ultrasound team received training in Dr. Zamboni’s original techniques from the Buffalo Neuroimaging Analysis Center, and they have created ultrasound and brain imaging procedures suited to explore venous drainage in children. Dr. Banwell’s team reports that recruitment is going well, and that they plan to analyze findings only after all 90 participants have undergoing the testing. Read details of Dr. Banwell’s original study plans.

• Dr. Fiona Costello, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta:
Once her team received Research Ethics Board approval, they began recruiting a cross-section of people with MS who would be compared with those affected by other neurological diseases or healthy volunteers. They have three dedicated ultrasound technologists who have been trained to do scanning as originally done by Dr. Zamboni, and they have refined their scanning protocol. The team is planning to repeat scans on a subset of participants who had been scanned before they made method changes, which will allow them to compare the sensitivity of results pre- and post-training. Dr. Costello’s team slowed recruitment briefly to upgrade to a new 3 Tesla (3T) MRI scanner (twice as strong as standard clinical MRI), and they have expanded their MRI team to include two additional, experienced members. The 3T machine went online in March 2011 and it is now being used to perform MR venography scans to compare against the ultrasound tests. Read details of this team’s original study plans.

• Dr. Aaron Field, University of Wisconsin School of Medicine and Public Health, Madison:
His team is now actively recruiting participants to undergo MR venography and ultrasound techniques originally used by Dr. Zamboni to investigate CCSVI in people with early and later stages of MS, controls with other conditions and healthy volunteers, now that they have received approval of the study from the Institutional Review Board. Their ultrasound expert has received training in the Zamboni techniques. The team has refined its MR venography protocol to account for variations in blood flow that occur with breathing and heartbeats. They have determined that they will use a relatively new contrast agent or dye that will permit high-quality images of the veins in the head and neck and for measuring blood flow in the brain. This will enable the entire MRI/MRV exam to be completed with one time-saving injection instead of two. They have also standardized locations along the length of veins where they take blood flow measurements because they have found large differences in both anatomy and size of head and neck veins. The team has submitted a meeting abstract reporting on their protocol development for consideration at the International Magnetic Resonance Angiography Workshop to be held September 25-28, 2011 in Calgary, Alberta, Canada. Read details of this team’s original study plans.


• Dr. Robert Fox, Cleveland Clinic Foundation, Cleveland:
After his team received IRB approval for using MR venography, ultrasound, MRI and clinical measures in people with MS or who are at risk for MS (CIS) and comparison groups, they began recruiting and scanning participants. The ultrasound team, which underwent training in the technique originally used by Dr. Zamboni, found several aspects of the published methodology ambiguous, and they have standardized the protocol and analysis to achieve consistent results.

They shared their solutions to these methodological challenges in a poster presented at the American Academy of Neurology’s annual meeting in April 2011 (Abstract P01.263). The poster outlined physiological and technical factors that can complicate screening for vein blockages using ultrasound, including that heartbeat irregularities, stages of breathing, head position and pressure applied by the operator could alter results; and that the state of hydration of the subject (whether they drank adequate amounts of fluids) could impact results of several of the criteria used to determine CCSVI. They concluded that these complications may help explain the mixed results reported thus far related to CCSVI and MS, and they have added to their aims a study designed to evaluate the impact of hydration on CCSVI assessments.

Dr. Fox’s team has also gathered autopsy specimens of venous tissue from 9 MS tissue donors and 6 donors who did not have MS. The team first had to develop and standardize techniques for studying these specimens for signs of CCSVI. They are analyzing their data and have submitted abstracts reporting preliminary findings related to this pathology study and their scanning results for consideration at the international ECTRIMS (European Committee for Treatment and Research in MS) meeting in October 2011. Read details of this team’s original study plans.


• Dr. Carlos Torres, The Ottawa Hospital, University of Ottawa, Ontario:
His team obtained Research Ethics Board approval after negotiating details over elements of the informed consent form used to explain the study’s procedures and potential outcomes to participants. The team has been conducting the first phase of scanning, using MRI and MR venography, in people without MS, which will be used to compare with various scans in people with MS. Three team members have been trained using the ultrasound techniques originally used by Dr. Zamboni, and they are on track recruiting more participants for the study. Dr. Torres expects to finalize phase 1 of the study by the end of the summer and then will move on to phase 2, which involves people with MS and other controls. Read details of this team’s original study plans.

• Dr. Anthony Traboulsee, UBC Hospital MS Clinic, UBC Faculty of Medicine and Dr. Katherine Knox, Saskatoon MS Clinic, University of Saskatchewan:
After both sites received Research Ethics Board approval they began to recruit, they have scanned a significant number of participants, and the level of interest in the MS community remains high. Their ultrasound technologists were trained by Dr. Zamboni, and they are also using catheter venography and MR venography to investigate the prevalence of CCSVI in people with MS and controls without MS. After the radiologists at both sites met in February 2011 to ensure the consistency of their protocols, they did a second wave of recruitment and hope to finish all testing before the end of 2011. Read details of their original study plans.

• Dr. Jerry Wolinsky, University of Texas Health Science Center at Houston:
After receiving IRB approval, the team began recruiting participants, and their neurosonographer received intensive training for intracranial and extracranial ultrasound scanning techniques. The team has already scanned a significant number of participants, which include people with different types of MS, people with other conditions, and people with no known health problems. The team is testing whether other imaging methods can confirm the ultrasound findings, while identifying the most reliable technique to screen for CCSVI. Dr. Wolinsky’s team continues to encounter difficulty in recruiting non-MS control subjects who don’t have a personal interest in the purpose of the trial. The executive committee that oversees this study has agreed with the team’s plan to continue aggressively recruit other controls, while at the same time increasing the number of MS participants. In some cases they have also found that some participants who were contacted to go into the next phase of scanning informed the investigators that they had gotten the venoplasty procedure, which made them ineligible to continue in the study. Read details of this team’s original study plans.

Going Forward: These seven teams were chosen by an international panel of experts that included specialists drawn from all key relevant disciplines including radiology, vascular surgery and neurology. The projects were selected for having the greatest potential to quickly and comprehensively determine the significance of CCSVI in the MS disease process. (Read more)

At this one-year milepost the investigators are making significant progress on their overall two-year study goals. The teams are making plans for sharing preliminary results at upcoming medical meetings, and have demonstrated a clear willingness to share technical advice so that the projects can move forward as smoothly and quickly as possible. Their results will help guide the development of a phase I/II clinical trial recently announced by the Canadian Federal Minister of Health to test whether treating vein blockages may be safe and effective in treating people with MS.

The next update on the work of the seven grantees will be reported in six months

Update Provided on CCSVI Research Progress

The National Multiple Sclerosis Society provides a progress report on the seven research projects being conducted on various aspects of Chronic Cerebrospinal Venous Insufficiency (CCSVI) with $2.4 million society funding.  This is like mid-term grades.  It is good to know how you are doing, but better to know that there is still plenty of time to get down to business before the year (or project) is over. 

(Yes, the music students have all been bemoaning the dreaded mid-term deadline of tests and grades at school.  That's why the phrase is on my mind.)

These seven research projects do not represent the ONLY research being conducted into CCSVI in the United States or Canada.  For information regarding additional research studies, including treatment trials, visit the CCSVI Alliance 'Clinical Trials in the US' webpage.  CCSVI Alliance is a non-profit organization which "promotes education and research about CCSVI and its relationship to Multiple Sclerosis (MS) by providing objective information to the MS community, supporting medical investigations of CCSVI, and fostering collaboration among patients, advocates, and professionals."

In addition to the press release/progress report reprinted below, CCSVI Alliance patient advisory board member and MS blogger we know as the Wheelchair Kamikaze, Marc Stecker was heard on NPR's Morning Edition show this morning - "Doctor Challenges Cause of MS and Treatment."


Research Teams Report Progress from First Six Months of 2-Year Projects Focusing on CCSVI and MS 

National MS Society, January 31, 2011 - Six-month progress reports from seven multi-disciplinary teams investigating CCSVI (chronic cerebrospinal venous insufficiency) in MS indicate that they have established rigorous protocols, are successfully recruiting participants, and are on-track to evaluate and deliver important data when the two-year projects are completed. All seven studies are two years in length but will be closely monitored while in progress in order to expedite clinical trials should the data show it is warranted. The studies were launched on July 1, 2010 with a more than $ 2.4 million commitment from the MS Society of Canada [$700,000] and the National MS Society (USA).

Most of the teams have received approval to begin their studies from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a required first step established by regulatory authorities to protect human subjects involved in research projects. (Read more about steps involved in conducting clinical research.)

Already more than 200 people have undergone scanning with various imaging technologies being used by the studies, including the Doppler ultrasound technology originally used by Dr. Paolo Zamboni and his collaborators, as well as magnetic resonance studies of the veins (MR venography), catheter venography, MRI scans of the brain, and clinical measures.

Owing to the significant interest in the MS community about CCSVI, we are providing 6-month updates rather than the more standard 12-month reporting cycle. Because the studies employ rigorous blinding and controls designed to attain objective and comprehensive data, the full results of the ongoing research will be available only after significantly more scans have been completed and evaluated. They will collectively involve more than 1300 people representing a spectrum of MS types, severities and durations, as well as individuals with other disease types and healthy controls.

“We are pleased with the progress reported by the research teams we have funded,” advised Dr. Tim Coetzee, chief research officer at the National MS Society, “and look forward to providing as quickly as possible the understanding and answers these projects reveal on the relationship between CCSVI and the MS disease process.”

Jon Temme, senior vice-president of research and programs for the MS Society of Canada concurs, “The grants were selected for having the greatest potential to quickly and comprehensively determine the significance of CCSVI in the MS disease process. It is very encouraging to see how effectively the work has advanced among all groups.”

Details: The funded investigators, which include an integration of both MS and vascular experts, report progress in establishing their teams, putting their protocols in place, recruiting participants and beginning their studies, as summarized below.

• Dr. Brenda Banwell, The Hospital for Sick Children, Toronto, Ontario: Her team received Research Ethics Board approval in the fall and has begun enrolling participants and studying vein abnormalities in children and teenagers who have MS, and healthy controls of the same age, using non-invasive MRI measures of vein anatomy and novel measures of venous flow, as well as ultrasound. The team’s ultrasound experts have received training in Dr. Zamboni’s original techniques. Read details of Dr. Banwell’s plan.

• Dr. Fiona Costello, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta: Her team received Research Ethics Board approval in the fall to begin recruiting a cross-section of people with MS compared to other neurological diseases and healthy volunteers. They also recruited two ultrasonography experts who have begun ultrasound scanning as originally used by Dr. Zamboni. Dr. Costello’s team slowed recruitment briefly to upgrade to a new 3T MRI machine (twice as strong as standard clinical MRI) that will be used to perform MR venography scans to compare against the ultrasound tests. Read details of Dr. Costello's plans.

• Dr. Aaron Field, University of Wisconsin School of Medicine and Public Health, Madison: His team will be using MR venography and ultrasound techniques originally used by Dr. Zamboni to investigate CCSVI in people with early and later MS, controls with other conditions and healthy volunteers. A study coordinator is developing a recruitment list and an ultrasound expert has been hired and is slated to receive training in the Zamboni techniques. Dr. Field has been negotiating with the Institutional Review Board on issues related to study details and informed consent, and hopes to have these issues resolved to obtain IRB approval in the coming weeks so that scanning can begin. Read details of Dr. Field’s plans.

• Dr. Robert Fox, Cleveland Clinic, Cleveland: His team has received Institutional Review Board approval for using MR venography, ultrasound, MRI and clinical measures in people with MS or who are at risk for MS (CIS) and comparison groups, and recruitment is ongoing. Two ultrasound researchers underwent training in the technique originally used by Dr. Zamboni, and the team has obtained a new ultrasound machine previously used in other CCSVI studies. The ultrasound team found several aspects of the published methodology ambiguous, and they have standardized the protocol and analysis to achieve consistent results. To share ideas and solutions to these methodological challenges, Dr. Fox’s team has submitted an abstract for consideration for presentation at the American Academy of Neurology’s annual meeting in April. Read details of Dr. Fox’s plans.

• Dr. Carlos Torres, The Ottawa Hospital, University of Ottawa, Ontario: His team obtained Research Ethics Board approval in the winter and at once began the first phase of scanning using MR venography in people without MS, which will be used to compare with various scans in people with MS. Dr. Torres’s team has overcome several obstacles including negotiating with the Research Ethics Board over elements of the informed consent form used to explain the study’s procedures and potential outcomes to participants. Team members are slated to be trained using the ultrasound techniques originally used by Dr. Zamboni, and they are on track recruiting more participants for the study. Read details of Dr. Torres' plans.

• Dr. Anthony Traboulsee, UBC Hospital MS Clinic, UBC Faculty of Medicine and Dr. Katherine Knox, Saskatoon MS Clinic, University of Saskatchewan: The teams at both sites have received Research Ethics Board approval and have begun to recruit and scan participants. Their ultrasound technologists were trained by Dr. Zamboni, and they are also using catheter venography and MR venography to investigate the prevalence of CCSVI in people with MS and controls without MS. The radiologists on the teams of Drs. Traboulsee and Knox are meeting in February 2011 to ensure the consistency of their protocols across sites. The teams are on target for accrual of recruits and completion of the study. Read details of this team's plans.

• Dr. Jerry Wolinsky, University of Texas Health Science Center at Houston: His team applied in advance and obtained Institutional Review Board approval in the spring, and the team’s neurosonographer has received intensive training for intracranial and extracranial ultrasound scanning techniques. The team has already scanned a significant number of participants, which includes people with different types of MS, people with other conditions, and people with no known health problems. One obstacle Dr. Wolinsky’s team is addressing is the difficulty of recruiting non-MS control subjects who don’t have a personal interest in the purpose of the trial. The team is testing whether other imaging methods can confirm the ultrasound findings, while identifying the most reliable technique to screen for CCSVI. Read details of Dr. Wolinsky’s plans.

Going Forward: These seven teams were chosen by an international panel of experts that included specialists drawn from all key relevant disciplines including radiology, vascular surgery and neurology. The grants were selected for having the greatest potential to quickly and comprehensively determine the significance of CCSVI in the MS disease process.

The teams are now established and scanning procedures are underway at all but one of the study sites. Researchers have demonstrated a clear willingness to share technical advice and information so that projects can move forward as smoothly as possible. At this six-month milepost they are making significant progress on plans for these two-year studies.

The next update on the work of the seven grantees will be reported in six months.