Sep 04, 2012
Seven research projects investigating CCSVI (Chronic Cerebrospinal Venous Insufficiency) and MS -- launched with a $2.4 million investment by the National MS Society and the MS Society of Canada -- have reached the two-year milepost.
The funded multi-disciplined researchers have been reporting significant progress in their two-year study goals. As of July 2012, most of the investigators are in the process of completing their projects and expect to do so within the next year. Even though the work continues for several of the teams, some are already presenting preliminary results at medical meetings, and all have shared technical advice so that the projects can move forward as smoothly and quickly as possible.
The need for continued work beyond the two-year grant funding period is not uncommon, as practical and logistical issues begin impacting on projected timelines, including such items as:
• getting proper protocols in place;
• applying for and gaining approvals from the required Institutional Review Boards in the U.S. or the Research Ethics Board in Canada, a first step established by regulatory authorities to protect human subjects involved in research projects;
• getting technicians and other team members trained on how to conduct appropriate screenings; and
• recruiting study participants.
After the research projects are completed, the studies will be analyzed and submitted for publication in one or more scientific journals so that peers can evaluate and comment on the findings. Currently it is not yet known when the full data and results will be available, though updates will continue as appropriate to reflect the ongoing transparency of the work being supported by the U.S and Canadian MS Societies. Results from the seven projects, as well as other studies underway around the globe, will help guide our planning for future investments in this area of research.
Research project highlights and progress
• The teams include an integration of experts drawn from all key relevant disciplines including neuroradiology, neurovascular imaging, MS imaging, vascular surgery, biostatistics, interventional radiology, interventional neuroradiology and MS clinical neurology. Bringing together experts across these areas will help to facilitate understanding of CCSVI in MS as quickly as possible.
• The research teams have recruited and scanned a broad spectrum of people with MS and others to build understanding of who may be affected by CCSVI. In addition they are refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process.
• Already more than 900 people have undergone scanning with various imaging technologies being used by the studies, including the Doppler ultrasound technology used by Dr. Paolo Zamboni and his collaborators, as well as magnetic resonance studies of the veins (MR venography), catheter venography, MRI scans of the brain, and clinical measures.
Some of the teams have been trained in, and are using, the ultrasound technique originally published by Dr. Zamboni. Others are using the same methods but are utilizing standard Doppler ultrasound machines rather than purchasing the specific machine used by Dr. Zamboni’s team.
Future Steps – Clinical Trial and Live Webcast Planned
Grantee results will help guide future steps, including the development of a clinical trial to test whether treating vein blockages is a safe and effective therapy for people with MS. The Canadian Institutes of Health Research (CIHR) announced in April 2012 that a research team had been chosen to conduct a phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. The location of the study has not yet been announced. The clinical trial is a collaborative initiative between the CIHR and the MS Society of Canada.
At this point, no connection has been confirmed between CCSVI and MS, in fact, CCSVI appears to occur in many people who do not have MS. Although some individuals who have MS have undergone surgical procedures for CCSVI, there has not yet been a controlled trial to determine its effectiveness in treating the symptoms or course of the disease. In addition, the U.S. FDA has issued a safety communication about potential risks associated with procedures and devices used to treat CCSVI, encouraging additional research.
The National MS Society shares in the public urgency to advance the understanding of CCSVI as quickly as possible, and is urging researchers to complete their studies and to analyze and publish their results as soon as possible. The Society plans to host a live Webcast in the spring of 2013 as a forum for discussion about the progress made in the understanding of CCSVI and MS.
For those who may not want to wait for research results in order to get tested for CCSVI and/or who want to undergo surgical treatment now, this is a personal decision to be discussed with their healthcare providers. To get the most reliable results about benefits and risks of any surgical procedure that might attempt to address blood flow in or out of the brain, as well as to further the overall understanding of CCSVI and how it may affect people diagnosed with MS, it is important that such surgery be performed as part of controlled trials, especially in light of adverse events reported to date.