Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy

Dileep Nair(Johns Hopkins University), Kenneth D. Laxer(Johns Hopkins University), Peter Weber(Johns Hopkins University), Anthony M. Murro(Johns Hopkins University), Yong D. Park(Johns Hopkins University), Gregory L. Barkley(Johns Hopkins University), Brien Smith(Johns Hopkins University), Ryder P. Gwinn(Johns Hopkins University), Michael J. Doherty(Johns Hopkins University), Katherine H. Noe(Johns Hopkins University), Richard S. Zimmerman(Johns Hopkins University), Gregory K. Bergey(Johns Hopkins University), William S. Anderson(Johns Hopkins University), Christianne Heck(Johns Hopkins University), Charles Y. Liu(Johns Hopkins University), Ricky W. Lee(Johns Hopkins University), Toni Sadler(Johns Hopkins University), Robert B. Duckrow(Johns Hopkins University), Lawrence J. Hirsch(Johns Hopkins University), Robert E. Wharen(Johns Hopkins University), William O. Tatum(Johns Hopkins University), Shraddha Srinivasan(Johns Hopkins University), Guy M. McKhann(Johns Hopkins University), Mark Agostini(Johns Hopkins University), Andreas V. Alexopoulos(Johns Hopkins University), Barbara C. Jobst(Johns Hopkins University), David W. Roberts(Johns Hopkins University), Vicenta Salanova(Johns Hopkins University), Thomas C. Witt(Johns Hopkins University), Sydney S. Cash(Johns Hopkins University), Andrew J. Cole(Johns Hopkins University), Gregory A. Worrell(Johns Hopkins University), Brian N. Lundstrom(Johns Hopkins University), Jonathan Edwards(Johns Hopkins University), Jonathan J. Halford(Johns Hopkins University), David Spencer(Johns Hopkins University), Lia Ernst(Johns Hopkins University), Christopher Skidmore(Johns Hopkins University), Michael R. Sperling(Johns Hopkins University), Ian Miller(Johns Hopkins University), Eric B. Geller(Johns Hopkins University), Michel J. Berg(Johns Hopkins University), A. James Fessler(Johns Hopkins University), Paul Rutecki(Johns Hopkins University), Alica M. Goldman(Johns Hopkins University), Eli M. Mizrahi(Johns Hopkins University), Robert E. Gross(Johns Hopkins University), Donald C. Shields(Johns Hopkins University), Theodore H. Schwartz(Johns Hopkins University), Douglas Labar(Johns Hopkins University), Nathan B. Fountain(Johns Hopkins University), W. Jeff Elias(Johns Hopkins University), Piotr W. Olejniczak(Johns Hopkins University), Nicole R. Villemarette-Pittman(Johns Hopkins University), Stephan Eisenschenk(Johns Hopkins University), Steven N. Roper(Johns Hopkins University), Jane Boggs(Johns Hopkins University), Tracy A. Courtney(Johns Hopkins University), Felice T. Sun(Johns Hopkins University), Cairn G. Seale(Johns Hopkins University), Kathy L. Miller(Johns Hopkins University), Tara L. Skarpaas(Johns Hopkins University), Martha J. Morrell(Johns Hopkins University), on behalf of the RNS System LTT Study
Neurology
July 21, 2020
10.1212/wnl.0000000000010154
Cited by 482Open Access
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Abstract

OBJECTIVE: To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. METHODS: Adults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory. RESULTS: ). CONCLUSIONS: Adjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low. CLINICALTRIALSGOV IDENTIFIER: NCT00572195. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.

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