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CCSVI Study by the Wolinsky Team

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Study on CCSVI in MS at The University of Texas Health Science Center at Houston

In June 2010, the National MS Society (USA) and the MS Society of Canada committed over $2.4 million to support seven new research projects on the role of CCSVI (chronic cerebrospinal venous insufficiency) in MS, an abnormality of blood drainage from the brain and spinal cord in MS originally reported by Dr. Paolo Zamboni. The new projects take a comprehensive look at the structure and function of veins draining the brain and spinal cord in people representing a spectrum of MS types, severities and durations, and compare them to structure and function of veins in people with other diseases and healthy volunteers. The studies incorporate high standards of experimental blinding and controls designed to provide unbiased results. Read First Published Results from National MS Society-Funded CCSVI Study by this team.

Title: “CCSVI and its relationship to MS”

Jerry S. Wolinsky, MD
University of Texas Health Science Center at Houston
Houston, Texas
Term/Amount: 7/1/10-6/30/12; $574,958
  • A series of recent publications have suggested that some people with MS have obstructions in the veins that drain blood in the brain and spinal cord that may contribute to nervous system damage in MS.
  • Dr. Wolinsky assembled an expert team to increase understanding of CCSVI, testing several imaging methods.
  • Validating a reliable diagnostic approach and demonstrating that CCSVI is specific to MS and contributes to disease activity would be necessary first steps before controlled therapeutic trials may be attempted.
About the Investigator: Dr. Wolinsky is the Bartels Family and Opal C. Rankin Professor of Neurology and a member of the graduate faculty of the Graduate School of Biomedical Sciences at The University of Texas Health Science Center at Houston. He directs the MS Research Group and the MRI Analysis Center. Dr. Wolinsky received his MD from The University of Illinois in 1969, and completed residency training in clinical neurology and a fellowship in experimental neuropathology at The University of California San Francisco. He subsequently joined the faculty of The Johns Hopkins University Schools of Medicine, and Hygiene and Public Health before settling in Houston. Dr. Wolinsky is active in the design, conduct and analysis of clinical trials in MS and conducts basic and applied imaging research. He is Chair of the National Clinical Advisory Board of the National MS Society. Dr. Wolinsky is recognized in The Best Doctors in America and America's Top Doctors, and has authored over 200 publications relating to neurovirology, neuroimmunology, and MS.

Dr. Wolinsky’s collaborators in this project were a stellar cast from the university, including include the overseer of the university’s cerebral vascular disease program, its chair of diagnostic and interventional imaging, director of MR research, director of the MS clinic, and chief of cardiovascular MRI.

Project Details: Recent 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. This pilot study warrants a subsequent larger and better controlled study to definitively evaluate the possible impact of CCSVI on the disease process in MS.

Dr. Wolinsky assembled an expert team to increase our understanding of CCSVI. Using a comprehensive approach, this team first attempted to replicate the ultrasound methods used by Dr. Zamboni in 120 people with all major clinical types of MS, compared with 175 people in various non-MS control groups. Then, they sought to determine whether the findings could be validated by noninvasive imaging techniques, such as an MRI machine using a powerful magnet. The team included experts in MS, as well as experts from other fields such as vascular disease and venous imaging.

Validating a reliable diagnostic approach and demonstrating that CCSVI is specific to MS and contributes to disease activity would be necessary first steps before controlled therapeutic trials may be attempted.

Progress updates

July 2013: Team publishes additional results from study.

March 2013: Team publishes first results.

September 2012: Researchers continue with their progress in the seven Society-funded CCSVI studies in MS. Read about the most recent progress.

January 2012: The team reports that they have recruited about 82% of the expected study cohort. The cumulative number of volunteers recruited from study inception includes: 10 Healthy Volunteers; 34 Other Neurological Diseases; 22 Stroke/TIA; 12 CIS; 112 relapsing-remitting MS; 44 secondary-progressive MS; 1 progressive-relapsing MS; 15 primary-progressive MS. Of people with MS or CIS, 45 have undergone MR venography with advance MRI. In addition, to date 10 people with MS have consented to transluminal venography, 2 are scheduled for study and 4 have completed the procedure without complications. No therapeutic interventions are considered in these investigations.

Dr. Wolinsky and the team’s MR vascular expert, Dr. Larry Kramer, are members of the MS Scientific Expert Working Group established by the Canadian Institutes of Health Research (CIHR), in collaboration with the Multiple Sclerosis (MS) Society of Canada, and additional team members have participated in the meetings and provided advice to the CIHR as requested.

A summary of the team’s preliminary work was presented as a poster at the international ECTRIMS/ACTRIMS congress in October 2011. They used Doppler technology to evaluate venous drainage in a blinded fashion. They reported that of all participants, 48/162 fulfilled at least one of five criteria for anomalous venous outflow proposed by Dr. Zamboni; 10/48 fulfilled two criteria consistent with CCSVI; none fulfilled more than 2 criteria. There was no significant difference between people with MS and non-MS, or within MS subgroups. They also found no significant differences between MS and non-MS subjects for measures of cross-sectional areas of the internal jugular veins or for venous flow rates. The team concluded that thus far they find less CCSVI than previously reported by other groups. They are now focusing on whether ultrasound can be complemented or supplanted by MRV and/or transluminal venography. (P1108 -- “Prospective, case‐control study of CCSVI with imaging‐blinded assessment: progress report focused on neurosonography.” Barreto AD, Brod SA, Bui T, Jamelka J, Kramer LA, Ton K, Cohen AM, Lindsey JW, Nelson F, Narayana PA, Wolinsky JS (2011). MSJ 17(S10):S511‐2.)

In addition, two abstracts have been submitted for consideration for the 64th Annual Meeting of the American Academy of Neurology to be held in late April 2012.

Quotes from Dr. Jerry Wolinsky

  • “Periodically, therapeutic claims for new approaches to MS receive widespread attention… If CCSVI exists and is associated with MS, it must be independently confirmed.”
  • “This project will pursue four overlapped steps to develop understanding of this condition... Validating a reliable diagnostic approach and demonstrating an MS-specific association is prerequisite to any randomized, blinded therapeutic trial of venoplasty for MS.”

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