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.
Highlights
The average participant was 34 (611.4) years old with epilepsy for 19.6 (611.4) years
The RNS System (NeuroPace, Mountain View, CA) provides responsive stimulation directly to 1 or 2 seizure foci when abnormal electrocorticographic (ECoG) activity is detected, typically epileptiform activity that has been observed at the onset of electrographic seizures
A total of 256 participants were implanted with the neurostimulator and leads and 230 of these participants enrolled in the Long-Term Treatment (LTT) Study
Summary
The average participant was 34 (611.4) years old with epilepsy for 19.6 (611.4) years. The most common serious devicerelated 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%)
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