1. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures.
- Author
-
Bergey, Gregory, Morrell, Martha, Mizrahi, Eli, Goldman, Alica, King-Stephens, David, Nair, Dileep, Srinivasan, Shraddha, Jobst, Barbara, Gross, Robert, Shields, Donald, Barkley, Gregory, Salanova, Vicenta, Olejniczak, Piotr, Cole, Andrew, Cash, Sydney, Noe, Katherine, Wharen, Robert, Worrell, Gregory, Murro, Anthony, Edwards, Jonathan, Duchowny, Michael, Spencer, David, Smith, Michael, Geller, Eric, Gwinn, Ryder, Skidmore, Christopher, Eisenschenk, Stephan, Berg, Michel, Heck, Christianne, Van Ness, Paul, Fountain, Nathan, Rutecki, Paul, Massey, Andrew, ODonovan, Cormac, Labar, Douglas, Duckrow, Robert, Hirsch, Lawrence, Courtney, Tracy, Sun, Felice, and Seale, Cairn
- Subjects
Adolescent ,Adult ,Aged ,Deep Brain Stimulation ,Double-Blind Method ,Epilepsies ,Partial ,Female ,Follow-Up Studies ,Humans ,Male ,Middle Aged ,Prospective Studies ,Time Factors ,Treatment Outcome ,Young Adult - Abstract
OBJECTIVE: The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures. METHODS: All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS System). Participants had completed a 2-year primarily open-label safety study (n = 65) or a 2-year randomized blinded controlled safety and efficacy study (n = 191); 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy. RESULTS: The average participant was 34 (±11.4) years old with epilepsy for 19.6 (±11.4) years. The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month. The median percent seizure reduction in the randomized blinded controlled trial was 44% at 1 year and 53% at 2 years (p < 0.0001, generalized estimating equation) and ranged from 48% to 66% over postimplant years 3 through 6 in the long-term study. Improvements in quality of life were maintained (p < 0.05). The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection (9.0%) involving soft tissue and neurostimulator explantation (4.7%). CONCLUSIONS: The RNS System is the first direct brain responsive neurostimulator. Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years. This experience supports the RNS System as a treatment option for refractory partial seizures. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for adults with medically refractory partial onset seizures, responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years.
- Published
- 2015