Kimford J Meador1, Ritu Kapur2, David W Loring3, Andres M Kanner4, Martha J Morrell5. 1. Department of Neurology and Neurological Sciences, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305, USA. Electronic address: kmeador@stanford.edu. 2. NeuroPace, Inc., 455 N Bernardo Drive, Mountain View, CA 94043, USA. Electronic address: rkapur@neuropace.com. 3. Department of Neurology, Emory University, Atlanta, GA 30322, USA. Electronic address: dloring@emory.edu. 4. Department of Neurology, University of Miami, Miller School of Medicine, 1120 NW 14th Street, Room 1324, Miami, FL 33136, USA. Electronic address: a.kanner@med.miami.edu. 5. Department of Neurology and Neurological Sciences, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305, USA; NeuroPace, Inc., 455 N Bernardo Drive, Mountain View, CA 94043, USA. Electronic address: mmorrell@neuropace.com.
Abstract
PURPOSE: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint. METHODS: The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy. During a 4-month postimplant blinded period, patients were randomized to receive responsive stimulation or sham stimulation, after which all patients received responsive neurostimulation in open label to complete 2years. Quality of life (QOL) and mood surveys were administered during the baseline period, at the end of the blinded period, and at year 1 and year 2 of the open label period. RESULTS: The treatment and sham groups did not differ at baseline. Compared with baseline, QOL improved in both groups at the end of the blinded period and also at 1year and 2years, when all patients were treated. At 2years, 44% of patients reported meaningful improvements in QOL, and 16% reported declines. There were no overall adverse changes in mood or in suicidality across the study. Findings were not related to changes in seizures and antiepileptic drugs, and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced improvements in QOL. CONCLUSIONS: Treatment with targeted responsive neurostimulation does not adversely affect QOL or mood and may be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin.
RCT Entities:
PURPOSE: The primary efficacy and safety measures from a trial of responsive neurostimulation for focal epilepsy were previously published. In this report, the findings from the same study are presented for quality of life, which was a supportive analysis, and for mood, which was assessed as a secondary safety endpoint. METHODS: The study was a multicenter randomized controlled double-blinded trial of responsive neurostimulation in 191 patients with medically resistant focal epilepsy. During a 4-month postimplant blinded period, patients were randomized to receive responsive stimulation or sham stimulation, after which all patients received responsive neurostimulation in open label to complete 2years. Quality of life (QOL) and mood surveys were administered during the baseline period, at the end of the blinded period, and at year 1 and year 2 of the open label period. RESULTS: The treatment and sham groups did not differ at baseline. Compared with baseline, QOL improved in both groups at the end of the blinded period and also at 1year and 2years, when all patients were treated. At 2years, 44% of patients reported meaningful improvements in QOL, and 16% reported declines. There were no overall adverse changes in mood or in suicidality across the study. Findings were not related to changes in seizures and antiepileptic drugs, and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced improvements in QOL. CONCLUSIONS: Treatment with targeted responsive neurostimulation does not adversely affect QOL or mood and may be associated with improvements in QOL in patients, including those with seizures of either mesial temporal origin or neocortical origin.
Authors: Ishita Basu; Madeline M Robertson; Britni Crocker; Noam Peled; Kara Farnes; Deborah I Vallejo-Lopez; Helen Deng; Matthew Thombs; Clarissa Martinez-Rubio; Jennifer J Cheng; Eric McDonald; Darin D Dougherty; Emad N Eskandar; Alik S Widge; Angelique C Paulk; Sydney S Cash Journal: Brain Stimul Date: 2019-03-11 Impact factor: 8.955