Adriano H Moffa1, André R Brunoni1, Felipe Fregni2, Ulrich Palm3, Frank Padberg3, Daniel M Blumberger4, Zafiris J Daskalakis4, Djamila Bennabi5, Emmanuel Haffen5, Angelo Alonzo6, Colleen K Loo6. 1. Interdisciplinary Center for Applied Neuromodulation, University Hospital & Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of São Paulo, São Paulo, Brazil. 2. Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA. 3. Department of Psychiatry and Psychotherapy, Ludwig Maximilian University Munich, Munich, Germany. 4. Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, ON, Canada. 5. Department of Clinical Psychiatry, Clinical Investigation Center 1431 Inserm, EA 481 Neurosciences, University Hospital of Besancon and FondaMental Foundation, Créteil, France. 6. Black Dog Institute & School of Psychiatry, University of New South Wales, Sydney, Australia.
Abstract
BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. METHODS: We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. RESULTS: Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. LIMITATIONS: Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. CONCLUSIONS: Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD.
BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. METHODS: We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. RESULTS: Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. LIMITATIONS: Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. CONCLUSIONS: Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD.
Authors: Marom Bikson; Colleen A Hanlon; Adam J Woods; Bernadette T Gillick; Leigh Charvet; Claus Lamm; Graziella Madeo; Adrienn Holczer; Jorge Almeida; Andrea Antal; Mohammad Reza Ay; Chris Baeken; Daniel M Blumberger; Salvatore Campanella; Joan A Camprodon; Lasse Christiansen; Colleen Loo; Jennifer T Crinion; Paul Fitzgerald; Luigi Gallimberti; Peyman Ghobadi-Azbari; Iman Ghodratitoostani; Roland H Grabner; Gesa Hartwigsen; Akimasa Hirata; Adam Kirton; Helena Knotkova; Evgeny Krupitsky; Paola Marangolo; Ester M Nakamura-Palacios; Weronika Potok; Samir K Praharaj; Christian C Ruff; Gottfried Schlaug; Hartwig R Siebner; Charlotte J Stagg; Axel Thielscher; Nicole Wenderoth; Ti-Fei Yuan; Xiaochu Zhang; Hamed Ekhtiari Journal: Brain Stimul Date: 2020-05-12 Impact factor: 8.955
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