Epilepsy specialists at Wake Forest University Baptist Medical Center are testing an investigational device designed to control seizures in patients with epilepsy. The device is a responsive neurostimulator (RNS™ System) which is implanted in the brain, detects abnormal electrical activity in the brain and sends out electrical impulses to prevent seizures. Wake Forest Baptist is the only center in North Carolina, Tennessee and South Carolina to test the device made by NeuroPace.
“This technology offers new hope to patients who have not responded to other treatments currently available and continue to have seizures,” said William Bell, M.D., an epileptologist and principal investigator for the study at the medical center.
Unlike the vagal nerve stimulator, another implantable device to treat seizures, the RNS treats the exact area of the brain affected by seizures. These are often areas of the brain that cannot be safely removed by epilepsy surgery. Patients are unaware of the electrical impulses used to control their seizures.
To enroll in the study, patients must be between the ages of 18 and 70 and have had an average of three seizures per month for the last three months, despite being treated with medication for partial epilepsy.
Over 240 people will be enrolled in the study at 28 medical centers nationwide for a two- to three-year period. Patients will be asked to keep a diary of their seizure activity and use a laptop and data transmitter to send information from their device to neurologists at Wake Forest Baptist to analyze.
The device is surgically implanted in a patient’s head by Steven Glazier, M.D. a neurosurgeon at the medical center, and can be turned on and off by the patient’s neurologist. For the first four months, 50 percent of patients will have the device turned on and 50 percent will have their device off. Researchers will track each participant’s progress during this phase. For the last 18 months of the study, all patients will have their device turned on and will record their health status on a routine basis. Patients will continue to receive their current epilepsy treatment while participating in the study.
“In order to determine if the device is effective, we have to turn off the devices in one group to compare with the group with the devices that are turned on,” Bell said. “After a four-month window, then we will turn all the devices on and see what the benefit to the patient is.”
“We hope this will be a new option for patients with epilepsy who continue to have seizures,” Bell said.
Other colleagues participating in the study include: Neurologists Cormac O’Donovan, M.D., Maria Sam, M.D., and Mary Campagna-Gibson, M.D. Jo Shuping is the research coordinator for the study.
For more information about the study, call Jo Shuping at 336-716-8694.
Media Contact: Rae Bush (336) 716-6878, firstname.lastname@example.org; or Karen Richardson (336) 716-4453, email@example.com.
About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.