Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Neurology, 2020-09, Vol.95 (9), p.e1244

Ort / Verlag

United States

Erscheinungsjahr

2020

Quelle

MEDLINE

Beschreibungen/Notizen

• To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. 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. 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% ( < 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 ( < 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 ( < 0.05, 1-tailed χ ). 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. NCT00572195. This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.