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PROSPECTIVE RANDOMIZED ENDOVASCULAR THERAPY IN MULTIPLE SCLEROSIS (PREMiSe)
We are seeking participants for currently ongoing Prospective Randomized Endovascular Therapy in multiple sclerosis (PREMiSe) trial being conducted by the Departments of Neurology and Neurosurgery to evaluate the effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of MS.

Study volunteers will undergo catheter venography followed by a balloon angioplasty procedure. Study testing will include Doppler ultrasound, MRI with MRV, physical and neurological examinations, CT Angiogram (CTA) of the head and neck and CT Perfusion (CTP) of the head. All of these tests will be performed at baseline (prior to any treatment) and at 1 month after treatment. A subset of these tests will also be performed 3, 6 and 12 months post-treatment.

One important aspect of the study is that only 50% of the participants in this study will receive an interventional treatment using balloon angioplasty. The other 50% of participants will have the same procedure but without insertion of any balloons. Participants would not be told if they had the treatment that is being tested or, if they had what is known as a “sham” procedure. It is an important requirement of this study that prospective participants understand that it will not be disclosed if they did or did not receive treatment for CCSVI until 6 months after the close of enrollment and randomization.

1) Applications will be processed according to our study criteria and in the order they are received.

2) Once the team evaluates the information you provide in the questionnaire, you will be contacted to inform you if you are eligible for further screening.

You must be:
Adult MS must be supported by fulfillment of the McDonald criteria
Meet criteria for the presence of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri)
Have an EDSS score of 0-5.5
Have normal kidney functioning as supported by lab work performed within 2 months of MRI testing (within 2 weeks if other criteria are met)
Be able to communicate effectively
Pass screening for MRI and contrast agent safety
Be able to travel to Buffalo, NY to complete testing (we only have this site for testing)
You must not:
Be in active relapse or have steroid treatment in 30 days prior to MRI
Have any vascular or heart problems
Have severe cognitive impairment/dysfunction
Have a history of drug or alcohol abuse, cerebrovascular disease or cerebral vascular malformations, head injury or brain trauma
Have any vascular malformations (Bechet Disease, Budd Chiari Syndrome, Congenital vascular malformations, Deep Vein Thrombosis within the past year, Chronic Venous Insufficiency of the lower limbs)
Have an allergy to contrast
Be unwilling to undergo the endovascular treatment
Be pregnant or expect to be pregnant during participation
You can provide your contact information for immediate screening by completing a form athttp://vovici.com/wsb.dll/s/8727g4c369.

Please do not make any travel plans until your enrollment is confirmed. All testing procedures are paid for by the study research grants. However, there is no financial compensation for your participation, or travel and related expenses.

We kindly ask completion of only one contact information form per patient.

recent Buffalo study wrote:
If such trials establish an initial benefit for endovascular therapy, then properly powered Phase III clinical trials should be conducted to prove whether this type of treatment can be made widely available. However, in our opinion, until these steps are accomplished, there is no role for the endovascular treatment of CCSVI in MS patients outside of approved clinical trials.

In general, however, he agreed that the literature to date has been less than reliable, with many small observational studies, varied methodology, and what appears to be a bias for studies showing no relationship between CCSVI and MS being published in neurological journals, and those finding positive relationships being published in radiological journals.

One of the issues requiring definition is the various venous abnormalities themselves, not just the blockage of venous outflow but also the precise abnormalities that are causing any blockage, he noted. Multimodal studies that use more than 1 imaging technique to examine these abnormalities appear to be more reliable. Intravenous Doppler, for example, is perhaps the most reliable of these modalities, Dr. Zivadinov noted, allowing direct visualization of the abnormalities in the pulsatile venous setting.

"I really think that one of the key messages of this review paper is that we are making clear the importance of a multimodal approach, of standardized guidelines, and of understanding what you are looking at," Dr. Zivadinov concluded. "While there is a common knowledge among radiologists about how to perform diagnostic imaging and intervention on the extracranial vessels, there are no guidelines for CCSVI, and before people begin to do research studies and say it's something or it's not, they should understand the arguments and understand how to do it, and follow some guidelines."

The authors are critical, however, of the so-called Zamboni criteria that outline 5 abnormalities, the presence of 2 or more of which constitute CCSVI. "I think the binary composite of these criteria is probably the major confusion at the moment in the literature," he said. "Basically, if you don't find that second criteria, you are classifying all of your subjects as negative, although the patient or subject may have important venous abnormalities."

1eye wrote:Since we're on the subject, a couple of places boast the "full Haacke" protocol. Is it useful, or just information we can't use yet? If I went to Brooklyn (can't afford California, and they don't all use IVUS), would some 3d images come in handy?