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Mass General Hospital testing new epilepsy
therapy device
Clinical trial examines new
responsive brain stimulation technology
BOSTON - August 1, 2007 - In an effort to find a better therapy
and improve the lives of people with epilepsy, the Massachusetts
General Hospital (MGH) Epilepsy
Service is participating in the RNS™ System Pivotal Clinical
Investigation, a study to evaluate the safety and effectiveness
of a responsive brain stimulation device in reducing the frequency
of uncontrolled seizures. MGH is one of only 28 centers across the
country participating in this study.
"Of the more than 3 million people in the United States with
epilepsy, approximately 30 to 40 percent have seizures that cannot
be fully controlled with medications, leaving many unable to work
or drive," said Andrew Cole, MD, director of the MGH Epilepsy
Service. "We hope that for some patients the RNS device will
allow them to live fuller, richer lives, free from fear of unexpected
seizures."
NeuroPace, a Mountain View, California-based medical device manufacturer
and developer of the RNS system, is sponsoring the nationwide, multicenter
clinical study. The RNS system, implanted within the skull, is designed
to continuously monitor the brain's electrical activity. When it
identifies the "signature" of a seizure's onset, the device
can deliver brief and mild electrical stimulations with the intention
of suppressing the seizure before any symptoms occur.
Uncontrolled seizures related to epilepsy are generally treated
with antiepileptic medications. However, many individuals treated
with medication alone continue to experience seizures or have unacceptable
medication side effects. Uncontrolled epilepsy can severely diminish
quality of life and is often associated with depression. Some people
with severe epilepsy may be candidates for epilepsy surgery to remove
the part of the brain that triggers the seizures. The RNS system
investigation may be an option for people with uncontrolled seizures
who are not candidates for conventional epilepsy surgery.
Participants in the RNS system study must be from 18 to 70 years
of age and meet the following requirements: have disabling (significant
enough to impair functional abilities or day-to-day life) simple
motor seizures, complex partial seizures and/or secondarily generalized
seizures; failed treatment with a minimum of two antiepileptic medications;
experienced an average of three or more disabling seizures every
28 days for three consecutive periods prior to enrollment and have
no more than two epileptogenic regions in the brain. Final determination
regarding eligibility for the clinical research study is made by
the clinical research study staff. RNS system study sites are located
at leading research and university hospitals throughout the United
States, including Mass General. Interested participants are invited
to call (866) 904-6630 or log on to www.seizurestudy.com
for more details about where this clinical research study is being
conducted and to be pre-screened for participation.
Founded in 1811, the MGH is the third oldest general hospital in
the United States and the oldest and largest in New England. The
900-bed medical center offers sophisticated diagnostic and therapeutic
care in virtually every specialty and subspecialty of medicine and
surgery. Each year the MGH admits more than 46,000 inpatients and
handles nearly 1.5 million outpatient visits at its main campus
and health centers. Its Emergency Department records nearly 80,000
visits annually. The surgical staff performs more than 35,000 operations
and the MGH Vincent Obstetrics Service delivers more than 3,500
babies each year. The MGH conducts the largest hospital-based research
program in the country, with an annual research budget of approximately
$500 million. It is the oldest and largest teaching hospital of
Harvard Medical School, where nearly all MGH staff physicians serve
on the faculty. The MGH is consistently ranked among the nation's
top hospitals by US News and World Report.
Media Contact: Jennifer
Gundersen, MGH Public Affairs
Physician Referral Service: 1-800-388-4644
Information about Clinical Trials
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