Premium
Two‐year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial
Author(s) -
Heck Christianne N.,
KingStephens David,
Massey Andrew D.,
Nair Dileep R.,
Jobst Barbara C.,
Barkley Gregory L.,
Salanova Vicenta,
Cole Andrew J.,
Smith Michael C.,
Gwinn Ryder P.,
Skidmore Christopher,
Van Ness Paul C.,
Bergey Gregory K.,
Park Yong D.,
Miller Ian,
Geller Eric,
Rutecki Paul A.,
Zimmerman Richard,
Spencer David C.,
Goldman Alica,
Edwards Jonathan C.,
Leiphart James W.,
Wharen Robert E.,
Fessler James,
Fountain Nathan B.,
Worrell Gregory A.,
Gross Robert E.,
Eisenschenk Stephan,
Duckrow Robert B.,
Hirsch Lawrence J.,
Bazil Carl,
O'Donovan Cormac A.,
Sun Felice T.,
Courtney Tracy A.,
Seale Cairn G.,
Morrell Martha J.
Publication year - 2014
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/epi.12534
Subject(s) - epilepsy , adverse effect , medicine , neurostimulation , randomized controlled trial , stimulation , anesthesia , seizure types , deep brain stimulation , clinical endpoint , surgery , psychiatry , disease , parkinson's disease
Summary Objective To demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci. Methods Randomized multicenter double‐blinded controlled trial of responsive focal cortical stimulation (RNS System). Subjects with medically intractable partial onset seizures from one or two foci were implanted, and 1 month postimplant were randomized 1:1 to active or sham stimulation. After the fifth postimplant month, all subjects received responsive stimulation in an open label period ( OLP ) to complete 2 years of postimplant follow‐up. Results All 191 subjects were randomized. The percent change in seizures at the end of the blinded period was −37.9% in the active and −17.3% in the sham stimulation group (p = 0.012, Generalized Estimating Equations). The median percent reduction in seizures in the OLP was 44% at 1 year and 53% at 2 years, which represents a progressive and significant improvement with time (p < 0.0001). The serious adverse event rate was not different between subjects receiving active and sham stimulation. Adverse events were consistent with the known risks of an implanted medical device, seizures, and of other epilepsy treatments. There were no adverse effects on neuropsychological function or mood. Significance Responsive stimulation to the seizure focus reduced the frequency of partial‐onset seizures acutely, showed improving seizure reduction over time, was well tolerated, and was acceptably safe. The RNS System provides an additional treatment option for patients with medically intractable partial‐onset seizures.