title: Quality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation.
abstract: OBJECTIVE
  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.affiliation: Department of Neurology and Neurological Sciences, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305, USA. Electronic address: kmeador@stanford.edu.
authors.forename: Kimford J
authors.initials: KJ
authors.lastname: Meador
authors.affiliation: NeuroPace, Inc., 455 N Bernardo Drive, Mountain View, CA 94043, USA. Electronic address: rkapur@neuropace.com.
authors.forename: Ritu
authors.initials: R
authors.lastname: Kapur
authors.affiliation: Department of Neurology, Emory University, Atlanta, GA 30322, USA. Electronic address: dloring@emory.edu.
authors.forename: David W
authors.initials: DW
authors.lastname: Loring
authors.affiliation: 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.
authors.forename: Andres M
authors.initials: AM
authors.lastname: Kanner
authors.affiliation: 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.
authors.forename: Martha J
authors.initials: MJ
authors.lastname: Morrell
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect / Q000187:drug effects; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage*; D015331:Cohort Studies; D004311:Double-Blind Method; D000069279:Drug Resistant Epilepsy / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants
keywords: Brain stimulation; Depression; Epilepsy; Intractable seizures; Quality of life; Responsive stimulation