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

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 vi...

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Autores principales: Bergey, Gregory K., Morrell, Martha J., Mizrahi, Eli M., Goldman, Alica, King-Stephens, David, Nair, Dileep, Srinivasan, Shraddha, Jobst, Barbara, Gross, Robert E., Shields, Donald C., Barkley, Gregory, Salanova, Vicenta, Olejniczak, Piotr, Cole, Andrew, Cash, Sydney S., Noe, Katherine, Wharen, Robert, Worrell, Gregory, Murro, Anthony M., 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, O'Donovan, Cormac, Labar, Douglas, Duckrow, Robert B., Hirsch, Lawrence J., Courtney, Tracy, Sun, Felice T., Seale, Cairn G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339127/
https://www.ncbi.nlm.nih.gov/pubmed/25616485
http://dx.doi.org/10.1212/WNL.0000000000001280
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author Bergey, Gregory K.
Morrell, Martha J.
Mizrahi, Eli M.
Goldman, Alica
King-Stephens, David
Nair, Dileep
Srinivasan, Shraddha
Jobst, Barbara
Gross, Robert E.
Shields, Donald C.
Barkley, Gregory
Salanova, Vicenta
Olejniczak, Piotr
Cole, Andrew
Cash, Sydney S.
Noe, Katherine
Wharen, Robert
Worrell, Gregory
Murro, Anthony M.
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
O'Donovan, Cormac
Labar, Douglas
Duckrow, Robert B.
Hirsch, Lawrence J.
Courtney, Tracy
Sun, Felice T.
Seale, Cairn G.
author_facet Bergey, Gregory K.
Morrell, Martha J.
Mizrahi, Eli M.
Goldman, Alica
King-Stephens, David
Nair, Dileep
Srinivasan, Shraddha
Jobst, Barbara
Gross, Robert E.
Shields, Donald C.
Barkley, Gregory
Salanova, Vicenta
Olejniczak, Piotr
Cole, Andrew
Cash, Sydney S.
Noe, Katherine
Wharen, Robert
Worrell, Gregory
Murro, Anthony M.
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
O'Donovan, Cormac
Labar, Douglas
Duckrow, Robert B.
Hirsch, Lawrence J.
Courtney, Tracy
Sun, Felice T.
Seale, Cairn G.
author_sort Bergey, Gregory K.
collection PubMed
description 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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spelling pubmed-43391272015-02-25 Long-term treatment with responsive brain stimulation in adults with refractory partial seizures Bergey, Gregory K. Morrell, Martha J. Mizrahi, Eli M. Goldman, Alica King-Stephens, David Nair, Dileep Srinivasan, Shraddha Jobst, Barbara Gross, Robert E. Shields, Donald C. Barkley, Gregory Salanova, Vicenta Olejniczak, Piotr Cole, Andrew Cash, Sydney S. Noe, Katherine Wharen, Robert Worrell, Gregory Murro, Anthony M. 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 O'Donovan, Cormac Labar, Douglas Duckrow, Robert B. Hirsch, Lawrence J. Courtney, Tracy Sun, Felice T. Seale, Cairn G. Neurology Article 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. Lippincott Williams & Wilkins 2015-02-24 /pmc/articles/PMC4339127/ /pubmed/25616485 http://dx.doi.org/10.1212/WNL.0000000000001280 Text en © 2015 American Academy of Neurology This is an open access article distributed under the terms of the Creative Commons Attribution–Noncommercial No Derivative 3.0 License, which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.
spellingShingle Article
Bergey, Gregory K.
Morrell, Martha J.
Mizrahi, Eli M.
Goldman, Alica
King-Stephens, David
Nair, Dileep
Srinivasan, Shraddha
Jobst, Barbara
Gross, Robert E.
Shields, Donald C.
Barkley, Gregory
Salanova, Vicenta
Olejniczak, Piotr
Cole, Andrew
Cash, Sydney S.
Noe, Katherine
Wharen, Robert
Worrell, Gregory
Murro, Anthony M.
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
O'Donovan, Cormac
Labar, Douglas
Duckrow, Robert B.
Hirsch, Lawrence J.
Courtney, Tracy
Sun, Felice T.
Seale, Cairn G.
Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
title Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
title_full Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
title_fullStr Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
title_full_unstemmed Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
title_short Long-term treatment with responsive brain stimulation in adults with refractory partial seizures
title_sort long-term treatment with responsive brain stimulation in adults with refractory partial seizures
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339127/
https://www.ncbi.nlm.nih.gov/pubmed/25616485
http://dx.doi.org/10.1212/WNL.0000000000001280
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