MS-CCSVI Diagnostic Study

Background

In 2009, a study by Dr. Zamboni in Italy claimed that all patients with multiple sclerosis (MS) had significant blockages in the neck veins (jugular and azygous). Termed chronic cerebral spinal venous insufficiency (CCSVI), he believed this created back pressure into the brain and was an important cause of MS and MS symptoms. He treated 65 patients with vein dilation (angio or venoplasty) and some reported significant improvement, calling this the “liberation” treatment. The liberation treatment is not routinely performed in Canada.

The UBC/VCH MS Clinic CCSVI strategy

The CCSVI theory was identified by the Canadian MS community, the MS Society, Canadian Institute for Health Research (CIHR) and politicians as a research priority for MS. Local research priorities were realigned to meet this challenge and three major projects were undertaken: the BC registry, the BC-Saskatchewan diagnostic study, and the phase I/II CCSVI Treatment trial.

The BC CCSVI Registry, funded by the Province of British Columbia, followed 80 MS patients who had the liberation procedure performed out of country. Patient-reported outcomes were collected up to two years after the treatment. Approximately 50 per cent of patients reported an improvement in MS symptoms. However, for many the improvement was not sustained. Many of the serious complications reported were related to the use of stents (metal tubes to keep the veins open).

This study is completed and submitted for publication. The registry is now closed.

MS-CCSVI Diagnostic Study

The BC-Saskatchewan Diagnostic Study was funded by the MS Society of Canada, the Saskatoon City Hospital Foundation, the Lotte & John Hecht Memorial Foundation and the Vancouver General Hospital Foundation.

The study used catheter venography, considered a gold-standard approach for looking at blood vessels, and careful blinding of the team to avoid bias. There was no significant difference in the number of patients with MS, their siblings, and unrelated volunteers who had narrowing of the neck veins.

CCSVI as described by Dr. Zamboni was rare, making it an unlikely cause of MS. This study is now completed.

Citation:

The phase I/II treatment trial funded by the Canadian Institutes of Health Research (CIHR), the Michael Smith Foundation for Health Research, the Provinces of Manitoba and Quebec involves four Canadian centres (Vancouver, Winnipeg, Montreal and Quebec City). Approximately 100 MS patients are participating in this blinded sham controlled trial to determine if venoplasty improves MS symptoms and is safe.

This study completed enrolment in 2015 with results expected in 2017 after all patients have completed at least one year of follow-up. For more information on the progress of this trial, visit clinicaltrials.gov