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

Full Text via DOI: 10.1212/WNL.0000000000010154 PMID: 32690786

Cited authors

  • Nair, Laxer, Weber, Murro, Park, Barkley, Smith, Gwinn, Doherty, Noe, Zimmerman, Bergey, Anderson, Heck, Liu, Lee, Sadler, Duckrow, Hirsch, Wharen, Tatum, Srinivasan, McKhann, Agostini, Alexopoulos, Jobst, Roberts, Salanova, Witt, Cash, Cole, Worrell, Lundstrom, Edwards, Halford, Spencer, Ernst, Skidmore, Sperling, Miller, Geller, Berg, Fessler, Rutecki, Goldman, Mizrahi, Gross, Shields, Schwartz, Labar, Fountain, Elias, Olejniczak, Villemarette-Pittman, Eisenschenk, Roper, Boggs, Courtney, Sun, Seale, Miller, Skarpaas, Morrell, RNS System LTT Study

Abstract

  • OBJECTIVE\nMETHODS\nRESULTS\nCONCLUSIONS\nCLINICALTRIALSGOV IDENTIFIER\nCLASSIFICATION OF EVIDENCE\nTo prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years.\nAdults 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.\nOf 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a ≥90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced ≥1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04-9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed χ2).\nAdjunctive 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.\nNCT00572195.\nThis study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.

Authors

Publication date

  • 2020

PubMed Central ID

  • PMC7538230

International Standard Serial Number (ISSN)

  • 0028-3878

Start page

  • e1244

End page

  • e1256

Volume

  • 95

Issue

  • 9