Personalized, Multisession, Multichannel Transcranial Direct Current Stimulation in Medication-Refractory Focal Epilepsy: An Open-Label Study.

Autor:	Kaye HL; Neuromodulation Program and Division of Epilepsy and Clinical Neurophysiology, Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A.; F. M. Kirby Neurobiology Center; Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A.; Behavioral Neuroscience Program, Division of Medical Sciences, Boston University School of Medicine, Boston, Massachusetts, U.S.A., San-Juan D; Clinical Neurophysiology Department, National Institute of Neurology and Neurosurgery of Mexico, Mexico City, Mexico., Salvador R; Neuroelectrics Barcelona, Barcelona, Spain., Biagi MC; Neuroelectrics Barcelona, Barcelona, Spain., Dubreuil-Vall L; Neuroelectrics Corporation, Cambridge, U.S.A.; and., Damar U; Neuromodulation Program and Division of Epilepsy and Clinical Neurophysiology, Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A.; F. M. Kirby Neurobiology Center; Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A., Pascual-Leone A; Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew Senior Life, Department of Neurology, Harvard Medical School, Boston, Massachusetts, U.S.A.; Guttmann Brain Health Institute, Institut Gutmann, Universitat Autonoma, Barcelona, Spain., Ruffini G; Neuroelectrics Barcelona, Barcelona, Spain.; Neuroelectrics Corporation, Cambridge, U.S.A.; and., Shafi MM; Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, U.S.A., Rotenberg A; Neuromodulation Program and Division of Epilepsy and Clinical Neurophysiology, Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A.; F. M. Kirby Neurobiology Center; Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, U.S.A.; Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, U.S.A.
Jazyk:	angličtina
Zdroj:	Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society [J Clin Neurophysiol] 2023 Jan 01; Vol. 40 (1), pp. 53-62. Date of Electronic Publication: 2021 May 14.
DOI:	10.1097/WNP.0000000000000838
Abstrakt:	Purpose: Animal and proof-of-principle human studies suggest that cathodal transcranial direct current stimulation may suppress seizures in drug-resistant focal epilepsy. The present study tests the safety, tolerability, and effect size of repeated daily cathodal transcranial direct current stimulation in epilepsy have not been established, limiting development of clinically meaningful interventions. Methods: We conducted a 2-center, open-label study on 20 participants with medically refractory, focal epilepsy, aged 9 to 56 years (11 women and 9 children younger than18 years). Each participant underwent 10 sessions of 20 minutes of cathodal transcranial direct current stimulation over 2 weeks. Multielectrode montages were designed using a realistic head model-driven approach to conduct an inhibitory electric field to the target cortical seizure foci and surrounding cortex to suppress excitability and reduce seizure rates. Patients recorded daily seizures using a seizure diary 8 weeks prior, 2 weeks during, and 8 to 12 weeks after the stimulation period. Results: The median seizure reduction was 44% relative to baseline and did not differ between adult and pediatric patients. Three patients experienced an increase in seizure frequency of >50% during the stimulation period; in one, a 36% increase in seizure frequency persisted through 12 weeks of follow-up. Otherwise, participants experienced only minor adverse events-the most common being scalp discomfort during transcranial direct current stimulation. Conclusions: This pilot study supports the safety and efficacy of multifocal, personalized, multichannel, cathodal transcranial direct current stimulation for adult and pediatric patients with medication-refractory focal epilepsy, although identifies a possibility of seizure exacerbation in some. The data also provide insight into the effect size to inform the design of a randomized, sham-stimulation controlled trial. Competing Interests: R. Salvador, M. C. Biagi, L. Dubreuil-Vall, A. Pascual-Leone, and G. Ruffini have received compensation from Neuroelecrics Inc., manufacturers of the tested device. G. Ruffini is a shareholder of Neuroelectrics. R. Salvador, M. C. Biagi, and L. Dubreuil-Vall are employed by Neuroelectrics. A. Pascual-Leone serves on the scientific advisory boards for Starlab Neuroscience, Neuroelectrics, Magstim Inc., Nexstim, and Cognito and is listed as an inventor on several issued and pending patents on the real-time integration of transcranial magnetic stimulation with electroencephalography and MRI. A. Rotenberg is cofounder and serves on the scientific advisory board of Neuromotion. He is also presently or has recently participated on the advisory boards of Epihunter, Gamify, Neurorex, and Roche. He has had research support from Brainsway, CRE Medical, Kintai, Neuroelectrics, Roche, Sage, and Takeda. The remaining authors have no conflicts of interest to disclose. (Copyright © 2021 by the American Clinical Neurophysiology Society.)
Databáze:	MEDLINE
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