A University of British Columbia neurologist will lead a national clinical trial of a therapy for multiple sclerosis based on a theory called Chronic Cerebrospinal Venous Insufficiency (CCSVI).
The Honourable Leona Aglukkaq, Minister of Health, announced Sept. 28 that the national trial, to be led by Dr. Anthony Traboulsee, an Assistant Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health, has received the necessary medical and ethical approvals, and can now proceed.
The study seeks to determine the validity of CCSVI, which posits that a blockage of veins in the head and neck results in excessive brain iron. Its most prominent proponent, Dr. Paolo Zamboni of Italy, believes that CCSVI may play an important role in the symptoms that affect many MS patients and that treatment of CCSVI could improve their lives.
“Liberation treatment” is the term coined by Dr. Zamboni for the dilation or repair of these narrowed veins. A catheter with a balloon is inserted into the narrowed vein and then the balloon is inflated to correct the narrowing. Some surgeons have placed stents (metal tubes) in the narrowing to prevent blockages from recurring.
The research team will enroll 100 subjects. Patients will be randomized to receive venoplasty treatment (interventional radiology treatment using a balloon) or a sham treatment. Each group will “cross over” to the other treatment after a year, so all patients will receive the venoplasty at some point.
The hope is that this trial will provide evidence that can help concretely move forward the discussion on CCSVI in terms of how it relates to MS in terms of cause and effect, as well as potential treatment.
The recruitment of 100 patients in B.C. and Quebec will begin by November 1, 2012. Ethics approval is also being sought in Manitoba.
For specific information about this trial, please visit this page of the Vancouver Coastal Health Research Institute.
Funding of the $6 million 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.
“This 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,” said Dr. Traboulsee, who is President of the Canadian Network of MS Clinics.
“I’m pleased to congratulate the team of researchers who will be studying the safety and effectiveness of the CCSVI procedure,” said Minister Aglukkaq. “Our government is committed to working with the provinces and territories to advance research in MS with the goal of improving the health of Canadians who live with this debilitating disease.”
“The support that the Government of Canada and the MS Society of Canada has received from provincial and territorial partners is instrumental in the rollout of the clinical trial that will help ensure a shared national understanding of the procedure proposed by Dr. Paolo Zamboni,” said Dr. Alain Beaudet, President of CIHR.
“As we move through this important new phase of MS research, we look forward to Dr. Traboulsee and his team furthering the work of the Canadian research community and providing more insights about CCSVI for those living with MS,” said Yves Savoie, President and CEO of the MS Society of Canada.