Brain Stimulator Approved for Epilepsy Treatment

The FDA has approved a device that will help epilepsy patients who haven’t responded to medications.

The RNS Stimulator, implanted within the skull, is connected to one or two wires that are placed where the seizures are suspected to originate.

When the device detects abnormal electrical activity, it “responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

Epilepsy, characterized by seizures that affect both mental and physical functions, is the third most common neurological disorder, after Alzheimer’s and stroke. Seizures occure when nerve cells in the brain signal abnormally. According to the Epilepsy Foundation, epilepsy affects nearly 3 million people in the United States and is the third most common neurological disorder, after Alzheimer’s disease and stroke.

About 40 percent of people with epilepsy continue to have seizures despite treatment.

The FDA issued its approval following a three-month randomized control trial of 191 patients with drug-resistant epilepsy.

The study found that three months after the device was turned on, patients had a nearly 38 percent reduction in the number of seizures per month, compared with 17 percent of patients who had the device turned off.

At the end of three months, the median reduction in seizures was 34 percent with active use and about 19 percent with the device turned off. During the trial, 29 percent of patients with an active device experienced at least a 50 percent reduction in the overall number of seizures, compared to 27 percent for those with the implanted device turned off. A two-year follow-up showed a reduction in frequency of seizures as well. Patients with the device, even when it is turned off, can’t undergo MRI procedures, diathermy procedures, electroconvulsive the rapy or transcranial magnetic stimulation.  Side effects reported were were implant site infection and premature battery depletion.
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