Long-term treatment with responsive brain stimulation in adults with refractory partial seizures

Gregory K. Bergey; Martha J. Morrell; Eli M. Mizrahi; Alica Goldman; David King-Stephens; Dileep Nair; Shraddha Srinivasan; Barbara Jobst; Robert E. Gross; Donald C. Shields; Gregory Barkley; Vicenta Salanova; Piotr Olejniczak; Andrew Cole; Sydney S. Cash; Katherine Noe; Robert Wharen; Gregory Worrell; Anthony M. Murro; Jonathan Edwards; Michael Duchowny; David Spencer; Michael Smith; Eric Geller; Ryder Gwinn; Christopher Skidmore; Stephan Eisenschenk; Michel Berg; Christianne Heck; Paul Van Ness; Nathan Fountain; Paul Rutecki; Andrew Massey; Cormac O'Donovan; Douglas Labar; Robert B. Duckrow; Lawrence J. Hirsch; Tracy Courtney; Felice T. Sun; Cairn G. Seale

doi:10.1212/WNL.0000000000001280

Long-term treatment with responsive brain stimulation in adults with refractory partial seizures

Gregory K. Bergey, Martha J. Morrell, Eli M. Mizrahi, Alica Goldman, David King-Stephens, Dileep Nair, Shraddha Srinivasan, Barbara Jobst, Robert E. Gross, Donald C. Shields, Gregory Barkley, Vicenta Salanova, Piotr Olejniczak, Andrew Cole, Sydney S. Cash, Katherine Noe, Robert Wharen, Gregory Worrell, Anthony M. Murro, Jonathan EdwardsMichael Duchowny, David Spencer, Michael Smith, Eric Geller, Ryder Gwinn, Christopher Skidmore, Stephan Eisenschenk, Michel Berg, Christianne Heck, Paul Van Ness, Nathan Fountain, Paul Rutecki, Andrew Massey, Cormac O'Donovan, Douglas Labar, Robert B. Duckrow, Lawrence J. Hirsch, Tracy Courtney, Felice T. Sun, Cairn G. Seale

Neurology & Neurotherapeutics

Research output: Contribution to journal › Article › peer-review

446 Scopus citations

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.

Original language	English (US)
Pages (from-to)	810-817
Number of pages	8
Journal	Neurology
Volume	84
Issue number	8
DOIs	https://doi.org/10.1212/WNL.0000000000001280
State	Published - Feb 24 2015

ASJC Scopus subject areas

Clinical Neurology

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Bergey, G. K., Morrell, M. J., Mizrahi, E. M., Goldman, A., King-Stephens, D., Nair, D., Srinivasan, S., Jobst, B., Gross, R. E., Shields, D. C., Barkley, G., Salanova, V., Olejniczak, P., Cole, A., Cash, S. S., Noe, K., Wharen, R., Worrell, G., Murro, A. M., ... Seale, C. G. (2015). Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology, 84(8), 810-817. https://doi.org/10.1212/WNL.0000000000001280

Bergey, GK, Morrell, MJ, Mizrahi, EM, Goldman, A, King-Stephens, D, Nair, D, Srinivasan, S, Jobst, B, Gross, RE, Shields, DC, Barkley, G, Salanova, V, Olejniczak, P, Cole, A, Cash, SS, Noe, K, Wharen, R, Worrell, G, Murro, AM, Edwards, J, Duchowny, M, Spencer, D, Smith, M, Geller, E, Gwinn, R, Skidmore, C, Eisenschenk, S, Berg, M, Heck, C, Van Ness, P, Fountain, N, Rutecki, P, Massey, A, O'Donovan, C, Labar, D, Duckrow, RB, Hirsch, LJ, Courtney, T, Sun, FT & Seale, CG 2015, 'Long-term treatment with responsive brain stimulation in adults with refractory partial seizures', Neurology, vol. 84, no. 8, pp. 810-817. https://doi.org/10.1212/WNL.0000000000001280

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title = "Long-term treatment with responsive brain stimulation in adults with refractory partial seizures",

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.",

author = "Bergey, {Gregory K.} and Morrell, {Martha J.} and Mizrahi, {Eli M.} and Alica Goldman and David King-Stephens and Dileep Nair and Shraddha Srinivasan and Barbara Jobst and Gross, {Robert E.} and Shields, {Donald C.} and Gregory Barkley and Vicenta Salanova and Piotr Olejniczak and Andrew Cole and Cash, {Sydney S.} and Katherine Noe and Robert Wharen and Gregory Worrell and Murro, {Anthony M.} and Jonathan Edwards and Michael Duchowny and David Spencer and Michael Smith and Eric Geller and Ryder Gwinn and Christopher Skidmore and Stephan Eisenschenk and Michel Berg and Christianne Heck and {Van Ness}, Paul and Nathan Fountain and Paul Rutecki and Andrew Massey and Cormac O'Donovan and Douglas Labar and Duckrow, {Robert B.} and Hirsch, {Lawrence J.} and Tracy Courtney and Sun, {Felice T.} and Seale, {Cairn G.}",

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year = "2015",

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doi = "10.1212/WNL.0000000000001280",

language = "English (US)",

volume = "84",

pages = "810--817",

journal = "Neurology",

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T1 - Long-term treatment with responsive brain stimulation in adults with refractory partial seizures

AU - Bergey, Gregory K.

AU - Morrell, Martha J.

AU - Mizrahi, Eli M.

AU - Goldman, Alica

AU - King-Stephens, David

AU - Nair, Dileep

AU - Srinivasan, Shraddha

AU - Jobst, Barbara

AU - Gross, Robert E.

AU - Shields, Donald C.

AU - Barkley, Gregory

AU - Salanova, Vicenta

AU - Olejniczak, Piotr

AU - Cole, Andrew

AU - Cash, Sydney S.

AU - Noe, Katherine

AU - Wharen, Robert

AU - Worrell, Gregory

AU - Murro, Anthony M.

AU - Edwards, Jonathan

AU - Duchowny, Michael

AU - Spencer, David

AU - Smith, Michael

AU - Geller, Eric

AU - Gwinn, Ryder

AU - Skidmore, Christopher

AU - Eisenschenk, Stephan

AU - Berg, Michel

AU - Heck, Christianne

AU - Van Ness, Paul

AU - Fountain, Nathan

AU - Rutecki, Paul

AU - Massey, Andrew

AU - O'Donovan, Cormac

AU - Labar, Douglas

AU - Duckrow, Robert B.

AU - Hirsch, Lawrence J.

AU - Courtney, Tracy

AU - Sun, Felice T.

AU - Seale, Cairn G.

PY - 2015/2/24

Y1 - 2015/2/24

N2 - 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.

AB - 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.

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Long-term treatment with responsive brain stimulation in adults with refractory partial seizures

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