TY  - JOUR
PY  - 2020//
TI  - Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy
JO  - Neurology
A1  - Nair, Dileep R.
A1  - Laxer, Kenneth D.
A1  - Weber, Peter B.
A1  - Murro, Anthony M.
A1  - Park, Yong D.
A1  - Barkley, Gregory L.
A1  - Smith, Brien J.
A1  - Gwinn, Ryder P.
A1  - Doherty, Michael J.
A1  - Noe, Katherine H.
A1  - Zimmerman, Richard S.
A1  - Bergey, Gregory K.
A1  - Anderson, William S.
A1  - Heck, Christianne
A1  - Liu, Charles Y.
A1  - Lee, Ricky W.
A1  - Sadler, Toni
A1  - Duckrow, Robert B.
A1  - Hirsch, Lawrence J.
A1  - Wharen, Robert E.
A1  - Tatum, William
A1  - Srinivasan, Shraddha
A1  - McKhann, Guy M.
A1  - Agostini, Mark A.
A1  - Alexopoulos, Andreas V.
A1  - Jobst, Barbara C.
A1  - Roberts, David W.
A1  - Salanova, Vicenta
A1  - Witt, Thomas C.
A1  - Cash, Sydney S.
A1  - Cole, Andrew J.
A1  - Worrell, Gregory A.
A1  - Lundstrom, Brian N.
A1  - Edwards, Jonathan C.
A1  - Halford, Jonathan J.
A1  - Spencer, David C.
A1  - Ernst, Lia
A1  - Skidmore, Christopher T.
A1  - Sperling, Michael R.
A1  - Miller, Ian
A1  - Geller, Eric B.
A1  - Berg, Michel J.
A1  - Fessler, A. James
A1  - Rutecki, Paul
A1  - Goldman, Alica M.
A1  - Mizrahi, Eli M.
A1  - Gross, Robert E.
A1  - Shields, Donald C.
A1  - Schwartz, Theodore H.
A1  - Labar, Douglas R.
A1  - Fountain, Nathan B.
A1  - Elias, W. Jeff
A1  - Olejniczak, Piotr W.
A1  - Villemarette-Pittman, Nicole R.
A1  - Eisenschenk, Stephan
A1  - Roper, Steven N.
A1  - Boggs, Jane G.
A1  - Courtney, Tracy A.
A1  - Sun, Felice T.
A1  - Seale, Cairn G.
A1  - Miller, Kathy L.
A1  - Skarpaas, Tara L.
A1  - Morrell, Martha J.
A1  - RNS System LTT Study, 
SP  - e1244
EP  - e1256
VL  - 95
IS  - 9
N2  - 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>
LA  - en
SN  - 0028-3878
UR  - http://dx.doi.org/10.1212/WNL.0000000000010154
ID  - ref1
ER  -