Friday, July 5, 2013 11:25 PM
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MS Karen
Recruitment Takes Off for Controversial Vein Therapy in MS Trialby AdvancesInMS / Jun. 28, 2013 A national clinical trial to test a controversial vein-opening procedure in people with MS has just received medical and ethical approvals in Canada.
The Phase I/II controlled study will monitor MS patients over two years to evaluate the long-term safety and effectiveness of the procedure used for chronic cerebrospinal venous insufficiency (CCSVI), commonly referred to as MS vein therapy. CCSVI was originally proposed by the Italian vascular surgeon Dr. Paolo Zamboni. His theory is that narrowed or blocked veins in the neck and head lead to the inefficient removal of blood from the brain and spinal cord (central nervous system). This can lead to lesions in the brain and inflammation.1 CCSVI treatments are offered in the U.S. and abroad and use ballooning and stents to unblock veins from the brain.
Reviews of research to date from around the world point to a strong relationship between CCSVI and MS, but results are contradicting and more high quality studies are needed, such as randomized controlled trials.2 While a recent study did not show that CCSVI played a strong role in causing MS3, CCSVI may be be a factor for some people with MS. Further studies are needed to better understand this connection.
MS researcher Dr. Anthony Traboulsee from Vancouver, Canada, will lead a $6-million study being funded by the Government of Canada, the MS Society of Canada and the provinces where the trial will take place. About 100 patients are expected to participate in the trial in British Columbia and Quebec, Canada. Recruitment for trial participants started on November 1, 2012. Ethics approval is still ongoing in Manitoba.4
Some participants will be randomly selected to receive the procedure called venoplasty (using a balloon, not a stent) while others will receive a “sham” treatment.4 A venoplasty to widen veins is the same technique as an angioplasty used to expand coronary arteries; a tiny balloon is fed into the blood vessel and then expanded.
At one year, participants will cross over to the other treatment, so that everyone will receive the venoplasty at some point. The hope is that this trial will provide evidence that helps advance the discussion on CCSVI in terms of how it relates to MS.
How to Participate Participants are currently being recruited from two sites, the UBC Hospital MS Clinic in Vancouver, British Columbia and the MS Clinic, Campus Notre-Dame du Centre hospitalier de l'Université de Montréal (CHUM) in Montreal, Quebec. The research team hopes to establish additional sites in Winnipeg and Quebec City.4
There are strict enrolment criteria in place. In order to participate, you:5
• must have documented confirmation of your MS diagnosis (either Relapsing Remitting, Secondary Progressive or Primary Progressive MS) • can only be enrolled through the trial sites • must be a resident of the province of a trial site (British Columbia or Quebec, to date) • must live within a distance that will allow for reasonable travel to the trial site • have never had a CCSVI procedure • must be able to walk with or without an assistive device for at least 20 meters • should not discontinue your current MS treatments • must be willing to remain in the study for two years
If you meet these criteria and are interested in participating, first speak with your health care team and then contact the trial site that is closest to you.
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