Wednesday, April 30, 2014

In the March issue of the journal Epilepsia, Dr. Heck and a group of doctors representing multiple centers across the United States present important results regarding the two year experience with the randomized, multi-centered, double-blinded, controlled trial of responsive focal cortical stimulation utilizing the RNS System.

  • During the trial, 191 individuals were randomized to active or a sham stimulation. After the fifth post-implant month all subjects received response to stimulation in an open label period to complete two years of post-implant followup.

  • The investigators found that the percent change in seizures at the end of the blinded period was approximately 37.9% in the active group and 17.3% in the sham stimulation group.

  • The median percent reduction in seizures in the open label period was 44% at one year and 53% at two years, representing a progressive and significant improvement with time.

  • The serious adverse event rate was not different between subjects receiving active and sham stimulation.

  • The adverse events were consistent with the known risk of an implanted medical device, seizures, and other epilepsy treatments.

  • There were no adverse effects on neuropsychological function or mood.

  • The investigators found that response to stimulation to the seizure focus reduced the frequency of partial onset seizures acutely, showed improving seizure reduction over time, was well tolerated, and was acceptably safe.

  • The RNS System provides an additional treatment option for patients with medically intractable partial onset seizures.

Authored by: Joseph I. Sirven, M.D. on 4/2014