Deep brain stimulation helped to reduce the frequency of a type of seizure in patients who hadn't responded to other treatments, according to data from a study published in the journal Epilepsia.
The SANTE study, which is evaluating Medtronic's deep brain stimulation therapy currently under review at the FDA, is the largest, most rigorous clinical study of DBS therapy for epilepsy in adults with medically refractory epilepsy with partial-onset seizures.
SANTE studied 110 participants with medically refractory partial seizures, half of whom were initially randomized to receive stimulation during a three-month blinded phase. All patients received stimulation after the blinded phase ended. By two years, there was a 56 median percent reduction in seizure; 54 percent had a seizure reduction of at least 50 percent; and 14 patients had been seizure-free for at least six months. Although five deaths occurred during the study, none was related to implantation or stimulation.
"The SANTE trial was a rigorous, well-designed, blinded trial with long-term follow up in an open-label phase. Based on the outcome of the study, DBS therapy holds promise for patients with epilepsy who are severely affected and have not had success with other treatments," according to Robert Fisher, professor of neurology and director of Stanford Epilepsy Center, principal investigator for the SANTE study and lead author.
An FDA panel recently recommended approval of the device by a narrow 7 to 5 margin, MedPage Today notes. However, such a narrow vote is not generally considered an endorsement.