TORONTOA long-awaited Canadian trial of a controversial experimental treatment for multiple sclerosis has been given the go-ahead and will soon begin recruiting patients, Health Minister Leona Aglukkaq announced Friday.
Aglukkaq, in Halifax for a meeting with provincial and territorial health ministers, said about 100 MS patients will be enrolled in the trial to assess the safety of the procedure to unblock narrowed neck veins and its efficacy in improving MS symptoms.
The condition dubbed chronic cerebrospinal venous insufficiency, or CCSVI has been proposed as a possible cause of MS by Italian vascular surgeon Paolo Zamboni.
More than three years ago, Zamboni hypothesized that narrowed and twisted veins in the neck and chest create a back-up of blood in the brain, resulting in iron deposits that could cause the brain lesions typical of MS.
The disease causes the destruction of myelin, the protective sheath around nerves throughout the body, leading to progressive physical and cognitive disability. An estimated 55,000 to 75,000 Canadians have MS, and the county has one of the highest rates of the incurable disease in the world.
Dr. Anthony Traboulsee, medical director of UBC Hospitals MS Clinic, will lead the $6-million study, which will be conducted initially in Vancouver and Montreal. Medical and ethical approval is also being sought for parts of the trial to be conducted in Quebec City and Winnipeg.
Its going to be a randomized-control study where patients who have the presence of CCSVI will be randomly selected to either have the venoplasty, which is dilation of the vein, or a sham treatment, which is not an actual dilation, just a pretend dilation, Traboulsee said Friday from Vancouver.
And after a year, the groups will switch so that everybody eventually gets the dilation of the vein.
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, then expanded.
None of the participants will know which treatment they received or during which half of the study, Traboulsee said.
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Multiple sclerosis: Canada launching clinical trial of controversial treatment developed by Zamboni
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