Letter from the Director
Dr. Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center
February 4, 2010
I write to you today as our researchers are completing their analysis of the first of several studies on chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS). The preliminary results are exciting scientifically and will generate a great deal of discussion among our colleagues and the wordwide press. The study itself continues into the second phase.
Good news! We will begin to offer CCSVI Diagnostic Venous Testing beginning this month. Patients may self-refer or be referred by their neurologist. We have also taken the first step towards treatment of CCSVI, a 6-month study titled, Controlled Randomized Endovascular Therapy (CRET). It will evaluate the safety and preliminary efficacy of therapeutic angioplasty. It is important to understand, however, that we cannot recommend endovascular treatment before we fully understand the safety of any approach we may propose. Thus, we intend to perform double-blind controlled trials using a treatment different from those used by either Prof. Zamboni or Prof. Michael Dake of Stanford. Many thanks to everyone who has been following our research, to those who participated in our first study and those interested in phase 2 of the CTEVD study.
We believe our CCSVI studies testing Dr. Paolo Zamboni’s controversial CCSVI theory will result in groundbreaking discoveries in the field of MS. Dr. Zamboni’s theory states that CCSVI is a complex vascular condition characterized by narrowing of the extra-cranial veins that restrict the normal outflow of blood from the brain.
This restriction then causes alterations in blood flow patterns within the brain that eventually cause injury to brain tissue and degeneration of neurons. As many of you are aware, enrollment in the first phase of the CTEVD study was closed in late December. What I can tell you today is that the preliminary results are exciting scientifically
and will generate a great deal of discussion among our colleagues, the worldwide press, and individuals like you
who are following very closely any developments about CCSVI. We are planning a press release by mid-February, as well as submission of these findings to the American Academy of Neurology annual conference as late breaking news.
I can further tell you that our research will pose new and provocative questions about the CCSVI theory which will be addressed in the second phase of the CTEVD Study. For this next phase, we will include an additional
500 participants who will be examined with a new Doppler machine specifically developed for CCSVI. In preparation,
statisticians are at this time working to determine how many subjects are needed for each age group, gender, and
level of MS progression. Once we have the numbers, applicants who fit the research profile will be contacted according to the order in which they completed the online questionnaire, and the second phase of screening will begin. When we have confirmed the requisite 500 new participants, we will notify by email the remaining individuals
(13,000+) who filled out the online questionnaire with hopes of participating in the study.
As scientists, we are, of course, excited to be engaged in developing a new understanding of MS, a disease that has confounded the medical profession for over 200 years. I speak for the entire BNAC-JNI research team and Dr. Bianca Weinstock-Guttman to let you know that this particular research is having an impact like no other we have known. We have been simultaneously humbled and inspired by the unprecedented volume of requests to participate in the CTEVD study.
At BNAC and JNI, we appreciate the urgency people with MS have exhibited to learn immediately, even before the definitive CCSVI research is complete, whether their veins are constricted. Therefore, in response to the overwhelming desire they have expressed since learning about the CCSVI theory, we have made a momentous decision. After consulting the Institutional Review Board at the University at Buffalo using preliminary results from the first phase of the CTEVD study that included 500 subjects, BNAC-JNI is pleased to announce that we will
begin to offer CCSVI Diagnostic Venous Testing beginning in mid-February 2010. Patients may be referred by their neurologists or be self-referred. Core testing will include the following:
• 3 Tesla MRI of the brain with quantitative measurement of the level of iron deposits in the brain on susceptibility-weighted imaging, with a report by a neuroradiologist
• 3 Tesla MRI of the neck aimed at visualization of the jugular, vertebral and other collateral veins, with a report by a
• Doppler exam of the head and neck to acquire images of the direction of venous blood flow in different body positions, with a report by a neuroradiologist
• Clinical visit that will provide assessment of patient status, discuss the findings and provide a comprehensive summary report with recommendations for the future There will also be optional examinations for neuro psychological and rehabilitation assessments, if necessary.
Testing for each patient will be done over two days here at Buffalo General Hospital. A new Doppler machine, specifically developed for CCSVI, will be used for all diagnostic procedures. BNAC-JNI will be the first Center
in North America to use such a machine, and will begin to provide training for other Centers that have expressed an interest in mastering the art of CCSVI diagnosis. We wanted to let people know now that they will be able to look to BNAC for comprehensive diagnosis of venous constriction. Furthermore, we realize that not all MS patients will be able to afford the costs of the diagnostic services in addition to travel to Buffalo. Therefore, we are planning to approach several major insurance providers to request reimbursement approval for these proposed diagnostic
tests. Please understand, however, that discussions and negotiations with these companies may take at least 18 months before reimbursements for CCSVI tests are approved. BNAC–JNI is proud to be one of the first neurology centers in North America to provide this comprehensive new patient service. We will use the expertise we have developed in our CCSVI research to diagnose venous blockage. With this knowledge, patients and their neurologists will be able to discuss appropriate next steps in their treatment.
see http:// bnac.net /newsletter/BNAC_Newsletter_02-04-2010.pdf for the rest of the newsletter.