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Chronic Cerebrospinal Venous Insufficiency (CCSVI)

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Studies Could Decide MS Theory's Validity

Preliminary studies have suggested that a phenomenon called Chronic Cerebrospinal Venous Insufficiency (CCSVI), a reported abnormality in blood drainage from the brain and spinal cord, may contribute to nervous system damage in MS. This hypothesis has been put forth by Dr. Paolo Zamboni from the University of Ferrara in Italy who published initial findings in June 2009 from a study of approximately 65 patients. There have been additional studies published since then, some of which showing results that conflict with the original findings. Read more about published studies to date.

National MS Society research leaders first met with Dr. Zamboni in February 2010 at New York University’s Society-funded MS Center of Excellence and again in April when the Society hosted, along with the American Academy of Neurology, a live Web forum on CCSVI. Based on the results of preliminary research which has been published in respected peer journals, Dr. Zamboni and others have recommended larger scale studies to determine if CCSVI may be treated through an endovascular surgical procedure, which involves inserting a tiny balloon or stent into blocked veins in order to improve the flow of blood out of the brain and spinal cord.  

Dr. Zamboni suggests that if further evidence supports the link between MS and CCSVI, that its treatment may ultimately add to the arsenal of therapies available for MS. He emphasized the need for more research on his hypothesis, and noted that people with MS should remain on their immunomodulatory therapies as has his wife after her endovascular surgical procedure.

This Lead is Being Pursued

The Society shares in the public urgency to advance the understanding of CCSVI as quickly as possible. In order to pursue new and unanticipated leads in MS, the National MS Society established the Rapid Response Fund. An example of this fund in action is the global outreach and expedited review process that led to the more than $2.4 million which the US Society, in collaboration with the MS Society of Canada, is devoting to the funding of seven initial grants that focus on the role of CCSVI in the MS disease process. Work has already begun on these grants. Read the 18-month progress report from these projects.

The seven new grants were chosen by an international panel of experts for having the greatest potential to quickly and comprehensively determine the significance of CCSVI and its relationship to MS. The chosen projects include an integration of experts drawn from all key relevant disciplines including radiology, vascular surgery and neurology. Bringing together experts across these areas will help to facilitate and speed the understanding of CCSVI in MS.

The new studies will carry out significant steps needed to confirm the phenomenon originally described by Dr. Paolo Zamboni and resolve the questions raised by him and others as to whether CCSVI is a cause of MS or related to MS in some other manner. These studies will also resolve conflicting data from previous research, such as how frequently CCSVI occurs in MS, and how often it occurs in people who do not have MS. If blockages are found, the findings will speed the way to determining whether therapeutic trials to correct them will be helpful in improving or altering MS disease process.

Adding clarity to the relationship between CCSVI and MS is essential in assisting people with MS secure any treatment they may consider. Medical institutions and health care providers require research data confirming the validity, necessity and safety of any procedure they provide, and in their view that data is not yet available as it relates to the relationship between CCSVI and MS.

Global Effort

This funding announcement is only a part of the global effort underway to pursue the CCSVI lead. The MS Society of Italy announced in June 2010 its intentions of supporting a 900,000 euro epidemiology study of CCSVI involving 1500 people with MS, bringing the international commitment of the MS Societies pursuing the CCSVI lead to nearly $3.4 million.

In late November 2011, the Canadian Institutes of Health Research (CIHR) announced intentions to release a Request for Proposals that seeks grant applications from researchers to conduct an early-phase clinical trial in Canada to test the ability of a surgical procedure called balloon venoplasty to improve blood drainage in individuals with MS who have been identified as having CCSVI. Read more  The request for research proposals is a collaborative initiative between the CIHR and the MS Society of Canada. A working group which includes members of the seven teams being funded by MS Societies in the U.S. and Canada will provide leadership and advice in the drafting of the protocol for the Phase I/II clinical trials in Canada, and will continue to monitor and analyze the data from the seven studies and other studies related to CCSVI and MS around the world.

It has also been reported that Dr. Zamboni is in the process of developing a randomized clinical trial comparing disease modifying therapy with and without balloon venoplasty with sponsorship from the Italian Government. Also, researchers from the University at Buffalo are undertaking a placebo-controlled trial involving 30 people with relapsing remitting MS, which may ultimately involve more depending on preliminary findings. A trial currently listed in the US clearinghouse registry "clinicaltrials.gov" is in Albany, NY, though it has not yet begun recruiting participants for the study.

The U.S. and Canadian MS Societies are working with the Multiple Sclerosis International Federation and other MS Societies from around the world to ensure coordination of information and to share research data from ongoing work that is underway around the world – further speeding progress.

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