BUFFALO, N.Y. -- Buffalo medical researchers led by a team from
the University at Buffalo Department of Neurosurgery, will embark
on a landmark prospective randomized double-blinded study to test
the safety and efficacy of interventional endovascular therapy
--dubbed "liberation treatment" -- on the symptoms and progression
of Multiple Sclerosis (MS).
Recent research has strongly associated chronic cerebrospinal
venous insufficiency (CCSVI) with MS.
In a series of original studies, Paolo Zamboni MD, of the
University of Ferrara, Italy, found blockage of major venous
outflow from the brain and spinal cord in patients with MS.
Researchers from many institutions, including the University at
Buffalo, have confirmed the association.
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 -- treatment commonly used by cardiologists and
other endovascular surgeons to treat atherosclerosis -- may remedy
Zamboni has conducted preliminary studies that suggest the
efficacy of venous angioplasty – "liberation procedure" -- in
the amelioration of MS symptoms.
Now, researchers at the University at Buffalo will launch
PREMiSe (Prospective Randomized Endovascular therapy in Multiple
Sclerosis), a study to determine if endovascular intervention via
balloon angioplasty to correct the blockages improves MS symptoms
PREMiSe is believed to be the first prospective randomized
double-blinded study of balloon angioplasty for MS being performed
with Institutional Review Board approval in a rigorous fashion in
the US with significant safeguards in place to ensure careful
determination of risks and benefits.
The study is led by principal investigator Adnan Siddiqui, MD,
assistant professor of Neurosurgery, UB School of Medicine and
Biomedical Sciences, with co-principal investigators Elad Levy, MD,
associate professor, and L.N. Hopkins, MD, professor and chair of
the UB Department of Neurosurgery
Additional independent researchers from University at Buffalo
will participate in the evaluation and follow-up of study patients.
An independent Data Safety Monitoring Board (DSMB) will ensure the
safety and effectiveness of the study on an ongoing basis.
In the first phase of the study, ten MS patients from the United
States and Canada who exhibit venous insufficiency will undergo
minimally invasive venous angioplasties to determine if the
procedure can be performed safely. The procedures began June 29 and
will continue today (June 30), performed by Siddiqui and Levy at
Kaleida Health's Millard Fillmore Gates Hospital in Buffalo, New
In its second phase, the study will randomize 20 MS patients who
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). The treatment will be blinded in such a way that
neither the patient undergoing the procedure nor the clinicians
evaluating the patient will be aware which procedure was
If results suggest an appropriate safety profile and preliminary
effectiveness, researchers will approach the University at Buffalo
IRB for an extension of the protocol to study a larger number of
patients in order to convincingly prove or disprove a causal
relationship between CCSVI and MS.
Multiple sclerosis is estimated to affect more than 400,000
people in the United States and more than two million people
worldwide. It is typically a disease of young adults characterized
by either a relapsing or progressive decline in neurologic function
resulting in significant disability. It is an inflammatory
neurological disease widely considered to be autoimmune in nature,
though its exact origins remain elusive.
If angioplasty is proven effective at improving MS symptoms, the
implications for the future of MS treatment could be monumental.
The physicians conducting PREMiSe are cautious but optimistic that
initial findings will be promising.
University at Buffalo Neurosurgery (UBNS) is an academic
neurosurgical group and leading regional referral center for
cerebrovascular disorders run by a distinguished team of
neurosurgical specialists and subspecialists committed to superior
patient care, resident education, and translational research. UBNS
diagnoses and treats a wide range of conditions, including but not
limited to aneurysms; stroke; back and neck pain; epilepsy;
Parkinson's disease; hydrocephalus; and tumors of the brain, spine,
and skull base. It is also the only neurosurgical group in Western
New York with FDA approval to conduct device-related clinical
trials for acute stroke.
The University at Buffalo is a premier research-intensive public
university, a flagship institution in the State University of New
York system and its largest and most comprehensive campus. UB's
more than 28,000 students pursue their academic interests through
more than 300 undergraduate, graduate and professional degree
programs. Founded in 1846, the University at Buffalo is a member of
the Association of American Universities.