Winnipeg Free Press - PRINT EDITION

'Liberation therapy' trial recruitment brisk

Manitobans play major role in nationwide clinical study

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A NATIONAL clinical trial testing the effectiveness of a controversial treatment for multiple sclerosis is halfway to meeting its recruitment goal, and Manitobans are playing a prominent role.

Dr. Anthony Traboulsee, director of UBC Hospital's MS Centre in Vancouver, the study's lead researcher, said 17 Manitobans are among the 51 Canadians enrolled so far. He hopes to have 100 MS sufferers recruited across the country by Feb. 1.

"I'm pretty confident that Winnipeg could potentially be the top recruiting site," Traboulsee said in a telephone interview on Friday. "All of the ducks have lined up in Manitoba beautifully."

Winnipeg is one of four sites for the $6-million national clinical trial announced in September 2012. The others are in Vancouver, Montreal and Quebec City.

The Manitoba government is footing part of the cost of the research.

The clinical trial is assessing the effectiveness of the so-called liberation therapy for treating MS pioneered by Italian researcher Dr. Paolo Zamboni in 2008. It involves improving blood flow in neck veins. The Italian vascular surgeon believes a condition, dubbed chronic cerebrospinal venous insufficiency, or CCSVI, is the cause of the disease.

Multiple sclerosis 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 country has one of the highest rates of the incurable disease in the world.

Some researchers and medical specialist have discounted the liberation treatment, but Traboulsee is keeping an open mind.

Hundreds, if not thousands, of Canadians have paid big bucks to have the procedure done abroad -- with mixed results.

Research has discredited part of Zamboni's theory but not all of it, Traboulsee said. Restricted blood flow in neck veins isn't unique to MS patients, as the Italian surgeon first theorized, but the jury is still out on whether improving blood flow can relieve the debilitating symptoms of the disease.

A survey of 300 people, mainly from British Columbia, who had undergone the treatment produced mixed results, Traboulsee said. About half found it to be very beneficial while half did not. "So I think it's important to pursue this to try to get clarity. Because if this is something beneficial, we want to make sure it's offered to the right people."

Each program participant will undergo the treatment over the course of two years, but they will not know when. At any one time, half will have the procedure done, while the rest will undergo a placebo treatment.

Traboulsee said some 51 persons have already been screened for the clinical trials in Manitoba, but not all MS sufferers qualify for various medical reasons. Some also bow out once the nature of the trials is fully explained to them.

The researcher said the pace of recruitment across the country so far is on target.

He said he's pleased with the numbers brought into the Winnipeg section of the trial. Only the Vancouver site has recruited more (20), and it got off to an earlier start.

He credited the work of Winnipeg lead investigator, Dr. Reza Vosoughi, and his team at Health Sciences Centre for the success in Manitoba so far.

Meanwhile, if all goes well, the national trials should begin producing preliminary results by February 2016 -- a year after enrolment is completed, Traboulsee said.

Republished from the Winnipeg Free Press print edition August 5, 2014 B1

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