A Canadian study that will test the so-called 鈥渓iberation treatment鈥� on people with multiple sclerosis has received the necessary medical and ethical approvals to go ahead.
Dr. Anthony Traboulsee, medical director of the UBC Hospital MS Clinic, and his team received ethics approvals from institutions in British Columbia and Québec and will now begin the process to begin a clinical trial into the procedure.
The main objective of the study will be to determine the safety of conducting angioplasty to open neck and chest veins, and to monitor how the procedure affects MS patients.
鈥淭his pan Canadian controlled study will allow us to monitor MS patients over a two-year period and obtain scientific evidence on the safety and efficacy of the CCSVI procedure in the long term,鈥� Dr. Traboulsee said in a statement Friday.
Patient recruitment for the study will begin on Nov. 1, 2012.
Approximately 100 patients are expected to participate in the trial, to be conducted in British Columbia and Québec.
The study is a collaborative effort of the Canadian Institutes of Health Research (CIHR), the MS Society of Canada and the provinces where the trial will take place. The study is expected to cost $6 million.
The liberation treatment is a procedure developed by Italian physician Dr. Paolo Zamboni. It鈥檚 based on his theory that narrowed neck veins are behind MS symptoms.
The narrowed neck veins, a condition he calls Chronic Cerebrospinal Venous Insufficiency, or CCSVI, reduces blood flow. That then allows iron deposits to build up in the brain, Zamboni believes.
Seven studies are currently underway in North America, sponsored by the MS Society of Canada and its U.S. counterpart, that are looking at whether vein abnormalities and MS are linked, as Zamboni proposed.
Saskatchewan plans to send patients to Albany, N.Y., for a clinical trial involving ballooning or a placebo.
In June, an observational study of people in Newfoundland and Labrador who travelled abroad for the treatment found no measurable benefit.
