Cited by 634Epilepsy research and treatmentVagus Nerve Stimulation ResearchDeep Brain Stimulation and Movement Disorders

The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index.

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

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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.

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Metadata

Authors
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., 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, R. B., Hirsch, L. J., Courtney, T., Sun, F. T., & Seale, C. G.
Affiliations
  • Johns Hopkins University (US)
  • Stanford University (US)
  • Baylor College of Medicine (US)
  • Author affiliations are provided at the end of the article.
  • Cleveland Clinic (US)
  • Columbia University (US)
  • Dartmouth College (US)
  • Emory University (US)
  • George Washington University (US)
  • Henry Ford Health (US)
  • Indiana University Bloomington (US)
  • Louisiana State University (US)
  • Harvard University (US)
  • Mayo Clinic (US)
  • Augusta University (US)
  • Medical University of South Carolina (US)
  • Oregon Health & Science University (US)
  • Rush University (US)
  • Swedish Medical Center (US)
  • Thomas Jefferson University (US)
  • University of Florida (US)
  • University of Rochester (US)
  • University of Southern California (US)
  • University of Virginia (US)
  • University of Wisconsin–Madison (US)
  • Cornell University (US)
  • Yale University (US)
Corresponding author
Morrell, Martha J.
Venue
Neurology
Published
2015-02-24
Volume
84
Issue
8
Pages
810-817
ISSN
  • 0028-3878 (ISSN-L)
  • 1526-632X
OpenAlex
W2119130526
Cited by
634
References
45
Citations by year
2026: 32 · 2025: 43 · 2024: 60 · 2023: 42 · 2022: 52 · 2021: 55 · 2020: 76 · 2019: 71 · 2018: 74 · 2017: 49 · 2016: 53 · 2015: 26
FWCI
54.34
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Neurology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • Massachusetts General Hospital
  • Yale University
  • University of Southern California
  • Emory University
  • George Washington University
  • Wake Forest University
  • Cleveland Clinic
  • Cleveland Clinic Foundation
  • Johns Hopkins University
  • University of Rochester
  • Louisiana State University
  • Dartmouth College
  • Thomas Jefferson University
  • Rush University
  • University of South Carolina
  • School of Medicine, Indiana University
Topics
  • Health Sciences › Medicine › Clinical Neurology › Epilepsy research and treatment
  • Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
  • Health Sciences › Medicine › Clinical Neurology › Deep Brain Stimulation and Movement Disorders
Keywords
responsive neurostimulation, refractory partial seizures, epilepsy, seizure reduction, long-term efficacy, device safety, implant site infection, quality of life, seizure foci
MeSH terms
Adolescent, Adult, Aged, Double-Blind Method, Epilepsies, Partial, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome, Deep Brain Stimulation, Young Adult

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CoChat. (2026). Citation check: Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. https://app.cochat.ai/papers/10.1212/wnl.0000000000001280
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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. https://doi.org/10.1212/wnl.0000000000001280