@article{ref1,
title="Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy",
journal="Neurology",
year="2020",
author="Nair, Dileep R. and Laxer, Kenneth D. and Weber, Peter B. and Murro, Anthony M. and Park, Yong D. and Barkley, Gregory L. and Smith, Brien J. and Gwinn, Ryder P. and Doherty, Michael J. and Noe, Katherine H. and Zimmerman, Richard S. and Bergey, Gregory K. and Anderson, William S. and Heck, Christianne and Liu, Charles Y. and Lee, Ricky W. and Sadler, Toni and Duckrow, Robert B. and Hirsch, Lawrence J. and Wharen, Robert E. and Tatum, William and Srinivasan, Shraddha and McKhann, Guy M. and Agostini, Mark A. and Alexopoulos, Andreas V. and Jobst, Barbara C. and Roberts, David W. and Salanova, Vicenta and Witt, Thomas C. and Cash, Sydney S. and Cole, Andrew J. and Worrell, Gregory A. and Lundstrom, Brian N. and Edwards, Jonathan C. and Halford, Jonathan J. and Spencer, David C. and Ernst, Lia and Skidmore, Christopher T. and Sperling, Michael R. and Miller, Ian and Geller, Eric B. and Berg, Michel J. and Fessler, A. James and Rutecki, Paul and Goldman, Alica M. and Mizrahi, Eli M. and Gross, Robert E. and Shields, Donald C. and Schwartz, Theodore H. and Labar, Douglas R. and Fountain, Nathan B. and Elias, W. Jeff and Olejniczak, Piotr W. and Villemarette-Pittman, Nicole R. and Eisenschenk, Stephan and Roper, Steven N. and Boggs, Jane G. and Courtney, Tracy A. and Sun, Felice T. and Seale, Cairn G. and Miller, Kathy L. and Skarpaas, Tara L. and Morrell, Martha J. and RNS System LTT Study, ",
volume="95",
number="9",
pages="e1244-e1256",
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: Of 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). 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.<p /><p>Language: en</p>",
language="en",
issn="0028-3878",
doi="10.1212/WNL.0000000000010154",
url="http://dx.doi.org/10.1212/WNL.0000000000010154"
}