A Canadian doctor is beginning his own before-and-after study of MS patients who are opting for the so-called liberation treatment.
Sandy McDonald, a cardiovascular surgeon in Barrie, Ont., hopes to recruit 250 MS patients for the study, which is aimed at assessing the results of the procedure to unblock neck veins.
The study will involve ultrasound imaging of the patient's neck veins and quality-of-life testing before and after for patients who undergo the procedure, which is not an approved treatment for multiple sclerosis in Canada.
Thousands of Canadians have travelled to centres in the United States, Europe, India and elsewhere that provide the unproven treatment, based on a theory, by Italian vascular surgeon Paolo Zamboni, that MS is linked to impaired blood flow from the brain due to blocked or twisted jugular and other neck veins.
The technique to correct the condition – which Dr. Zamboni calls chronic cerebro-spinal venous insufficiency, or CCSVI – involves unclogging the veins with balloon angioplasty, the same technique used to clear blocked coronary arteries.
Dr. McDonald, who was trained by Dr. Zamboni in his specific ultrasound technique to detect CCSVI, provides the diagnostic testing at his clinic in Barrie.
When MS patients seek the vein-clearing procedure at clinics outside Canada, there is little or no formal follow-up after they return home – so information about the condition of their neck veins, possible adverse effects and measures of whether the procedure alleviated symptoms are all lost, Dr. McDonald said.
"And what I'm trying to do is capture some of the data so that data isn't lost."
As part of the study, Dr. McDonald's clinic will repeat the ultrasound imaging to see if vein abnormalities have been corrected and to identify any complications, such as a blood clot that could result in a re-blocking of the vein.
"Unless you do a follow-up study, you don't know if a patient has that," said Dr. McDonald. "And if the patient has that, the question is: should it be treated as a standard DVT (deep vein thrombosis)? And my thought is it probably should."
Dr. McDonald is conducting his study in association with the U.S.-based Hubbard Foundation, which has international ethics approval for such research.
The foundation, begun by David Hubbard in San Diego, Calif., has undertaken research aimed at validating the existence of CCSVI and determining any link it may have to MS.
"We're not going to know the answer unless we do the research," said Dr. McDonald.
Dr. Zamboni's theory remains controversial and polarizing, with some patients and their advocates fully embracing the treatment, while others in the MS community take a wait-and-see attitude and doctors debate its scientific validity.
Results from a number of studies have so far varied widely in their results, although a recent pooling of findings suggested there is enough of an apparent link between CCSVI prevalence and people with MS to warrant further investigation.
"And clearly it needs to be done," said Dr. McDonald, noting that it is unclear whether CCSVI may cause MS or if the abnormal veins are a result of the progressively debilitating neurological condition.
While his study won't resolve that issue, he said "it may say if you have CCSVI and MS, if the CCSVI is treated, then your MS symptoms may improve."
Dr. McDonald said he is not receiving funding for his study, and patients will have to pay for their ultrasound assessment.