The US Food and Drug Administration (FDA) have approved the RNS Stimulator (Neuropace) to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.
“The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalise 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.
The FDA’s approval is supported by a three-month randomised control trial of 191 patients with drug-resistant epilepsy.
The study showed that by three months after the implanted device was turned on (active use) patients experienced a nearly 38% reduction in the average number of seizures per month, compared to an approximately 17% reduction in the average number of seizures per month in patients who had the implanted device turned off. At the end of three months, the median reduction in seizures, which reflects a more typical patient experience, was 34% with active use and about 19% with the device turned off. During the trial, 29% of patients with an active device experienced at least a 50% reduction in the overall number of seizures, compared to 27% for those with the implanted device turned off.
During a two-year follow-up phase (unblinded), data demonstrated a persistent reduction in seizure frequency.
Patients with RNS Stimulators cannot undergo magnetic resonance imaging (MRI) procedures, nor can they undergo diathermy procedures, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS). The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off.
The most frequent adverse events reported were implant site infection and premature battery depletion.