The University of Buffalo has announced that researchers there, led by the department of neurosurgery, have embarked on a landmark prospective randomized double-blinded study to test the safety and efficacy of interventional endovascular therapy—dubbed “liberation treatment”—on MS symptoms and progression. Ever since Paolo Zamboni, M.D., of the University of Ferrara, Italy, proposed more than a year ago that a blockage of major venous outflow from the brain and spinal cord in people with MS (a condition known as CCSVI) may be associated with the disease, the MS community has been anxious for further studies to distinguish the role of CCSVI in MS.
PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) is a study to determine if endovascular intervention via balloon angioplasty to correct the blockages improves MS symptoms or progression. PREMiSe is believed to be the first prospective randomized double-blinded study of balloon angioplasty for MS being performed in the US that has been approved by the University at Buffalo Institutional Review Board (IRB). Significant safeguards are reportedly in place to ensure careful determination of risks and benefits.
In the first phase of the study,10 MS patients from the United States and Canada exhibiting venous insufficiency will undergo minimally invasive venous angioplasties to determine if the procedure can be performed safely. The procedures, scheduled for June 29th and 30th will be performed at Kaleida Health’s Millard Fillmore Gates Hospital in Buffalo, N.Y.
The second phase of the study will randomize 20 MS patients to undergo either venous angioplasty or a “sham angioplasty” (a catheter will be inserted but there will be no inflation of the balloon). The treatment will be blinded in such a way that neither the person undergoing the procedure nor the clinicians evaluating the person will be aware which procedure was performed.
If results suggest an appropriate safety profile and preliminary effectiveness, then researchers will approach the IRB for an extension of the protocol to study a larger number of people with MS to convincingly prove or disprove a causal relationship between CCSVI and MS.
With CCSVI, it is hypothesized that the narrowing in the large veins in the neck and chest might cause improper drainage of blood from the brain, resulting in eventual injury to brain tissue. It is thought that angioplasty—a treatment commonly used by cardiologists and other endovascular surgeons to treat atherosclerosis—may remedy the blockages. Dr. Zamboni has further conducted preliminary studies suggesting the efficacy of venous angioplasty (“liberation procedure”) in the amelioration of MS symptoms.