Publication Date
9-1-2020
Journal
Neurology
DOI
10.1212/WNL.0000000000010154
PMID
32690786
PMCID
PMC7538230
PubMedCentral® Posted Date
9-1-2020
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Keywords
Adolescent, Adult, Aged, Depressive Disorder, Drug Resistant Epilepsy, Electric Stimulation Therapy, Epilepsies, Partial, Female, Follow-Up Studies, Humans, Implantable Neurostimulators, Intracranial Hemorrhages, Male, Memory Disorders, Middle Aged, Prospective Studies, Prosthesis-Related Infections, Quality of Life, Randomized Controlled Trials as Topic, Status Epilepticus, Sudden Unexpected Death in Epilepsy, Suicide, Treatment Outcome, Young Adult
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% (
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.
CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.