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UB launches clinical trial
of new MS treatment
Researchers from the UB Department of Neurosurgery have embarked on a landmark study to test the safety and efficacy of interventional endovascular therapy—dubbed “liberation treatment”—on the symptoms and progression of multiple sclerosis (MS).
The study advances recent research that has associated chronic cerebrospinal venous insufficiency (CCSVI) with MS.
Paolo Zamboni of the University of Ferrara in Italy found that CCSVI—a narrowing of the primary veins outside the skull—was strongly associated with MS, increasing the risk of developing MS by 43-fold. The association has been confirmed by independent researchers from many institutions, including UB.
Researchers believe that this narrowing restricts the normal outflow of blood from the brain, causing alterations in the blood-flow patterns within the brain that eventually cause injury to brain tissue and degeneration of neurons. It is thought that angioplasty—a treatment commonly used by cardiologists and other endovascular surgeons to treat atherosclerosis—may open the narrowed veins. Zamboni has conducted preliminary studies that suggest that a liberation procedure could be effective in ameliorating MS symptoms.
UB researchers now have launched PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis), a study to determine if using endovascular intervention via balloon angioplasty to open the narrowed veins improves MS symptoms or progression.
Adnan Siddiqui, assistant professor of neurosurgery, UB School of Medicine and Biomedical Sciences, is principal investigator on the study; co-principal investigators are Elad Levy, associate professor of neurosurgery, and L.N. Hopkins, professor and chair of the Department of Neurosurgery.
In the first phase of the study, 10 MS patients from the United States and Canada with symptoms of CCSVI underwent minimally invasive venous angioplasties last week to determine if the procedure could be performed safely. The procedures were performed by Siddiqui and Levy at Kaleida Health’s Millard Fillmore Gates Hospital.
In its second phase, 20 randomized MS patients will undergo either venous angioplasty or a “sham angioplasty” (i.e. a catheter will be inserted, but there will be no inflation of the balloon).
If results suggest the procedure is safe and effective, researchers will seek an extension of the protocol to study a larger number of patients.
Researchers note that if angioplasty proves to be effective in improving MS symptoms, the implications for the future of MS treatment could be monumental.
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