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Randomized Controlled Trial
. 2014 Mar;55(3):432-41.
doi: 10.1111/epi.12534. Epub 2014 Feb 22.

Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial

Christianne N Heck  1 , David King-Stephens, Andrew D Massey, Dileep R Nair, Barbara C Jobst, Gregory L Barkley, Vicenta Salanova, Andrew J Cole, Michael C Smith, Ryder P Gwinn, Christopher Skidmore, Paul C Van Ness, Gregory K Bergey, Yong D Park, Ian Miller, Eric Geller, Paul A Rutecki, Richard Zimmerman, David C Spencer, Alica Goldman, Jonathan C Edwards, James W Leiphart, Robert E Wharen, James Fessler, Nathan B Fountain, Gregory A Worrell, Robert E Gross, Stephan Eisenschenk, Robert B Duckrow, Lawrence J Hirsch, Carl Bazil, Cormac A O'Donovan, Felice T Sun, Tracy A Courtney, Cairn G Seale, Martha J Morrell
Affiliations
Randomized Controlled Trial

Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial

Christianne N Heck et al. Epilepsia. 2014 Mar.

Abstract

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.

Keywords: Cortical stimulation; Focal seizures; Neurostimulator; Partial seizures; Responsive stimulation.

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Figures

Figure 1
Figure 1
Implanted RNS Neurostimulator and NeuroPace Depth Lead and NeuroPace Cortical Strip Lead.
Figure 2
Figure 2
RNS System Pivotal Study Design.
Figure 3
Figure 3
RNS System Pivotal Study Subject Disposition.
Figure 4
Figure 4
Responder rate and median percent reduction in seizure frequency.
Figure 5
Figure 5
Seizure frequency percent change by subject: most recent 3 months.
Figure 6
Figure 6
Changes in QOLIE-89 primary scale scores at 2 years after implantation of the RNS Neurostimulator and Leads.
See this image and copyright information in PMC

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