In 2009 and early 2010 Direct-MS strongly supported ($125,000) clinical research at the University of Buffalo to determine if CCSVI was associated with MS or not. It is now clear that CCSVI is indeed highly associated with MS and is very likely a major contributor to the MS disease process.
Given the above, for the next two years (2010 -2012), Direct-MS will be focusing our research effort on funding a proper clinical trial which will test the effectiveness of venous angioplasty (CCSVI treatment) for relieving MS symptoms and for slowing/halting MS progression. This shift in research emphasis is due to the great promise CCSVI treatment holds for persons with MS and the reluctance of the MS Society of Canada and NMSS to support such clinical research at this time.
Such a trial is essential to establish the value of CCSVI treatment for MS. This in turn will allow CCSVI treatment to become available throughout Canada as part of the Canadian Health Care system and will make it much easier for US citizens to attain the necessary treatment through their insurance plans.
Once sufficient funds have been raised, Direct-MS will solicit research proposals related to clinical research on the effectiveness of CCSVI treatment for MS. The Direct-MS board, in conjunction with CCSVI experts, will evaluate all proposals to ensure any proposed research is scientifically valid. Acceptance or rejection of a proposal will be decided within a few months of receipt.
Direct-MS recently funded CCSVI and MS association research at the University of Buffalo and this was very successful. There is now no doubt that CCSVI is associated with MS and publications on this work will appear in scientific journals in 2011. Some of the U of Buffalo results are detailed in the Direct-MS webcast
Direct-MS has contributed $150,000 to the University of Buffalo PREMISE clinical trial which is testing the effectiveness of CCSVI treatment for MS. This trial just began in mid-2010 and some preliminary results will be available in 2011.
Direct-MS is funding a clinical trial into the effectiveness of the Terry Wahls nutritional regime and electrical stimulation for advanced MS. The work is being led by Dr Wahls at the University of Iowa. The trial began in the fall of 2010 and results should be available by 2012. A summary of this research can be found on the Direct-MS Facebook page
Direct-MS is also funding a study on the role on Vitamin D and Inflammatory Markers in Multiple Sclerosis. This work is being led by Dr Reinhold Vieth at University of Toronto and Mt Sinai Hospital.
Direct-MS has funded two major clinical trials over the past five years. These are;
Read more about the results of these trials here.
The abstract of the paper on the vitamin D trial which was recently published in Neurology (June 2010) is below.
Objective: Low vitamin D status has been associated with multiple sclerosis (MS) prevalence and risk, but the therapeutic potential of vitamin D in established MS has not been explored. Our aim was to assess the tolerability of high-dose oral vitamin D and its impact on biochemical, immunologic, and clinical outcomes in patients with MS prospectively.
Methods: An open-label randomized prospective controlled 52-week trial matched patients with MS for demographic and disease characteristics, with randomization to treatment or control groups. Treatment patients received escalating vitamin D doses up to 40,000 IU/day over 28 weeks to raise serum 25-hydroxyvitamin D [25(OH)D] rapidly and assess tolerability, followed by 10,000 IU/day (12 weeks), and further downtitrated to 0 IU/day. Calcium (1,200 mg/day) was given throughout the trial. Primary endpoints were mean change in serum calcium at each vitamin D dose and a comparison of serum calcium between groups. Secondary endpoints included 25(OH)D and other biochemical measures, immunologic biomarkers, relapse events, and Expanded Disability Status Scale (EDSS) score.
Results: Forty-nine patients (25 treatment, 24 control) were enrolled [mean age 40.5 years, EDSS 1.34, and 25(OH)D 78 nmol/L]. All calcium-related measures within and between groups were normal. Despite a mean peak 25(OH)D of 413nmol/L, no significant adverse events occurred. Although there may have been confounding variables in clinical outcomes, treatment group patients appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls.
Conclusions: High-dose vitamin D (>10,000 IU/day) in multiple sclerosis is safe, with evidence of immunomodulatory effects.