Mass General Hospital Testing New Epilepsy Therapy Device - Clinical Trial Examines New Responsive Brain Stimulation Technology

Main Category: Epilepsy
Also Included In: Clinical Trials / Drug Trials;  Neurology / Neuroscience
Article Date: 05 Aug 2007 - 2:00 PDT

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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 http://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.

Massachusetts General Hospital