Frequently Asked Questions about New CCSVI Grants
1) How many CCSVI grants are you funding and at what value?
The National MS Society (USA) and the MS Society of Canada have funded 7 projects investigating CCSVI (chronic cerebrospinal venous insufficiency) in MS, valued at a total of over $2.4 million. This expedited funding demonstrates Society-wide commitment to quickly follow all promising research avenues that have potential to move the field forward.
2) Who decided which new studies to fund, based on what criteria?
All research applications underwent a rigorous expedited review process by an international review panel that included experts drawn from all key relevant disciplines including: neuroradiology, neurovascular imaging, MS imaging, vascular surgery, biostatistics, interventional radiology, interventional neuroradiology, and MS clinical neurology. The U.S. National MS Society and the MS Society of Canada worked collaboratively to assemble the reviewers who considered scientific merit, responsiveness to the international Request for Applications, experimental design, likelihood of producing definitive data, and the experience of the applicant teams. The leadership of the US and Canadian MS Societies followed the panel’s recommendations and undertook the funding of these studies.
3) Why are these studies necessary, if it’s already been proven that CCSVI is involved in MS?
These new studies are necessary because we don’t yet know whether, or if so how, CCSVI contributes to MS disease activity. They will achieve several important goals. First, the new studies will carry out significant steps needed to confirm the phenomenon originally described by Dr. Paolo Zamboni who reported abnormalities in the veins draining the brain and spinal cord in people with MS and resolve the questions raised by him and others as to whether CCSVI is a cause of MS or related to MS in some other manner. Second, these studies will resolve conflicting data from previous research, such as how frequently CCSVI occurs in MS, and how often it occurs in people who do not have MS. Third, if blockages are found, the findings will speed the way to determining whether therapeutic trials to correct them will be helpful in improving or altering MS disease process.
4) Where will the new CCSVI studies be taking place?
The principal investigators are located at the following institutions. Some of these investigators also plan to collaborate with investigators at other locations. If any of these study sites announce the need to recruit participants locally, this will be announced on our Website.
USA sites, with links to summaries:
University of Wisconsin School of Medicine and Public Health, Madison
Cleveland Clinic, Cleveland
University of Texas Health Science Center at Houston
Canada sites, with links to summaries:
Hospital for Sick Children, Toronto, Ontario
Foothills Medical Centre, Calgary, Alberta
Ottawa Hospital, Ontario
University of British Columbia Hospital MS Clinic, UBC Faculty of Medicine and Saskatoon MS Clinic, University of Saskatchewan
5) What types of specialists comprise each research team?
Like the international advisory panel that reviewed the proposals and recommended the initial grants, the research teams selected bring together a diverse group of specialists in their respective fields to coordinate, execute and evaluate the various elements of each grant. As set forth in the grant details, multi-disciplinary teams include experts in vascular imaging, MRI and ultrasound, neurovascular imagery and neuroradiology, cerebral vascular and interventional imaging. Bringing together experts across these areas will help to facilitate understanding of CCSVI in MS as quickly as possible. The lead investigators cited in the grant summaries were the selection of each submitting institution.
6) Will these sites be recruiting participants for their CCSVI studies?
The need to recruit participants for these studies will differ, depending on the size and extent of the individual study.
7) When will recruitment for these studies begin? How can I get involved?
Funding began as of July 1, 2010 and recruitment has begun. Recruitment is on a per-project basis and may depend on a number of factors including: age, geographic location, previous treatment history, patient attendance at an MS clinic and other medical conditions to name a few. It is widely expected that desire to be involved with these studies will far exceed opportunities for participation. Regardless of one’s ability to participate, everyone with MS will benefit from the results of these studies.
If a there is a broad call for recruitment, the information will be posted on www.nationalmssociety/ccsvi when it becomes available.
8) Will these studies treat CCSVI?
These studies are not designed to treat CCSVI but rather to understand the prevalence and significance of the condition as it relates to MS, and to identify the best imaging technology to evaluate it. These are critical steps toward a better understanding of the relationship between CCSVI and MS disease process.
9) Why aren’t these studies focusing on treating CCSVI in MS?
These new studies will carry out the important steps necessary to confirm whether CCSVI contributes to MS disease activity and will resolve conflicting data from previous studies. The “blinding” of participants and researchers as well as the use of a comparative control group are essential to ensure that the hopes and expectations of the participants and the researchers do not influence the assessment of the trial outcomes and the interpretation of the results.
These findings will speed the way to determining whether therapeutic trials to correct blockages will be helpful in improving or altering disease process.
10) When will we see results from these studies?
The studies are two years in length and researchers expect to publish results in peer reviewed scientific journals as outcomes are established. The timing of data analysis, peer review and publication can vary widely and thus it is not possible to predict when results will be available.
As part of our commitment to keeping people with MS and the public informed of progress, researchers will be asked to provide 6-month interim updates to the National MS Society on their grant progress. Read the 18 month progress reports from all seven projects.
The U.S. and Canadian MS Societies are working with the Multiple Sclerosis International Federation and other MS Societies from around the world to ensure coordination of information and to share research data from ongoing work that is underway around the world – further speeding progress.
11) What will be the next steps after these studies are completed?
The new projects take a comprehensive look at the structure and function of veins draining the brain and spinal cord in people representing a spectrum of MS types, severities and durations, and compare them to the structure and function of veins in people with other diseases and healthy volunteers. The studies incorporate accepted high standards of experimental blinding and controls designed to provide unbiased results. They also use a variety of imaging technologies including the Doppler ultrasound technology originally used by Dr. Zamboni’s team.
Together, these studies aim to further understand the role of CCSVI in MS and identify optimal methods for screening for the condition, which would be necessary to determine the next steps required in advancing this CCSVI lead. Their results will also help guide the development of a therapeutic trials, including the 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.
12) Why were certain projects not funded?
Although there were a number of promising research submissions, the international review panel recommended those that combined the strongest science with the research goals necessary to move us forward as quickly as possible toward answers that could take us to the next steps in pursuing this CCSVI lead.
We hope that those who did not receive funding at this time consider re-applying under our regular review processes.
13) Who else applied for funding but did not get recommended for grants?
The National MS Society (USA) and MS Society of Canada share with other funding organizations accepted, long-standing policies not to reveal the identities of those who apply for research funding. This is a professional courtesy to the investigators who did not get recommended for funding.
14) How can I help support CCSVI research and What is the Rapid Response Fund?
The National MS Society has established a Rapid Response Fund to pursue new and unexpected research opportunities when they arise, such as expedited funding of these CCSVI grants. To support the Society’s Rapid Response Fund please have individuals email their full name and contact information to giftplanning@nmss.org.
15) What else is going on in MS research?
New CCSVI grants are only one of many exciting research avenues that address ways to stop MS progression, restore function and end MS forever. Check our Website for information on an upcoming live Webcast, June 30 on What’s New in MS Research and Treatment www.nationalMSsociety.org/june30webcast
Read CCSVI funding announcement
Read the 18 month progress reports from all seven projects
View a short video about CCSVI and MS
Read more and view programs about exciting research topics
Read additional FAQs About CCSVI related to the topic of CCSVI and its relation to MS.