作者
Christianne N Heck, 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
发表日期
2014/3
期刊
Epilepsia
卷号
55
期号
3
页码范围
432-441
简介
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 …
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CN Heck, D King‐Stephens, AD Massey, DR Nair… - Epilepsia, 2014