BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with a disabling progressive course. Chronic cerebrospinal venous insufficiency (CCSVI) has recently been described as a vascular condition characterized by restricted venous outflow from the brain, mainly due to blockages of the internal jugular and azygos veins. Despite a wide variability among studies, it has been found to be associated with MS. Data from a few small case series suggest possible improvement of the clinical course and quality of life by performing percutaneous balloon angioplasty (PTA) of the stenotic veins.
STUDY DESIGN: This is a multicenter, randomized, parallel group, blinded, sham-controlled trial to assess the efficacy and safety of PTA. Participants with relapsing remitting MS or secondary progressive MS and a sonographic diagnosis of CCSVI will be enrolled after providing their informed consent. Each participant will be centrally randomized to receive catheter venography and PTA or catheter venography and sham PTA. Two primary end points with respect to efficacy at 12 months are (1) a combined end point obtained through the integration of five functional indicators, walking, balance, manual dexterity, bladder control, and visual acuity, objectively measured by instruments; and (2) number of new brain lesions measured by T2-weighted MRI sequences. Secondary end points include annual relapse rate, change in Expanded Disability Status Scale score, proportion of patients with zero, one or two, or more than two relapses; fatigue; anxiety and depression; general cognitive state; memory/attention/calculus; impact of bladder incontinence; and adverse events. Six hundred seventy-nine patients will be recruited. The follow-up is scheduled at 12 months. Patients, treating neurologists, trained outcome assessors, and the statistician in charge of data analysis will be masked to the assigned treatment.
DISCUSSION: The study will provide an answer regarding the efficacy of PTA on patients' functional disability in balance, motor, sensory, visual and bladder function, cognitive status, and emotional status, which are meaningful clinical outcomes, beyond investigating the effects on inflammation. In fact, an important part of patients' expectations, sustained and amplified by anecdotal data, has to do precisely with these functional aspects. (NCT01371760).
The Brave Dreams trial is reported on clinical trials.gov to be recruiting, this is one of the trials of protagonists of CCSVI along with others. This trials is by Prof Zamboni
It appears that the Canadian Government has pledged to do a trial of 100 MSer, CCSVIers at a cost of $6,000,000 starting November 2012, so that's $60,000 a person to get sham plus active....that's about the presumed cost of Lemtrada! Added to this Canadian provinces are spending $2,000,000 sending 86 MSers to New York at a more modest $20,000 a person or so. The Canadian trial is being lead by a CCSVI sceptic, the New York trial by a CCSVI protagonist. Why has it taken so long?
Will the results be definitive. If positive, will we wheel-out the treatment, If negative is this the end of the treatment? The trials have been set to monitor change at 12 months but if you read the blog there is evidence that if the treatment does something , this is often not active after about 3 months. Do the veins re-block accounting for this?