Treatment of adult attention-deficit hyperactivity disorder (ADHD) with transcranial direct current stimulation (tDCS): study protocol for a parallel, randomized, double-blinded, sham-controlled, multicenter trial (Stim-ADHD).

Autor: Mauche N; Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Leipzig, Leipzig, Germany., Ulke C; Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Leipzig, Leipzig, Germany.; Department of Psychiatry and Psychotherapy, University Hospital, University of Leipzig Medical Center, University of Leipzig, Semmelweisstr. 10, 04103, Leipzig, Germany., Huang J; Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Leipzig, Leipzig, Germany., Franke A; Clinical Trial Centre Leipzig, Faculty of Medicine, University of Leipzig, Leipzig, Germany., Bogatsch H; Clinical Trial Centre Leipzig, Faculty of Medicine, University of Leipzig, Leipzig, Germany., Ethofer T; Department of Psychiatry and Psychotherapy, LEAD Graduate School and Research Network, University Hospital of Tübingen, Tübingen, Germany.; Department of Biomedical Magnetic Resonance, University Hospital of Tübingen, Tübingen, Germany., Grimm O; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt, Frankfurt am Main, Germany., Frodl T; Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen, RWTH Aachen University, Aachen, Germany., Hoffmann K; Department of Psychiatry, Psychotherapy and Preventive Medicine, Medicine Ruhr University, Bochum, Germany., Juckel G; Department of Psychiatry, Psychotherapy and Preventive Medicine, Medicine Ruhr University, Bochum, Germany., Kittel-Schneider S; Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, University Hospital, University of Wurzburg, Würzburg, Germany., Mehren A; Department of Psychiatry and Psychotherapy, University of Bonn, Bonn, Germany.; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands., Philipsen A; Department of Psychiatry and Psychotherapy, University of Bonn, Bonn, Germany., Plewnia C; Department of Psychiatry and Psychotherapy, LEAD Graduate School and Research Network, University Hospital of Tübingen, Tübingen, Germany., Reif A; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University Frankfurt, Frankfurt am Main, Germany., Ziegler GC; Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, University Hospital, University of Wurzburg, Würzburg, Germany., Strauß M; Department of Psychiatry and Psychotherapy, University Hospital, University of Leipzig Medical Center, University of Leipzig, Semmelweisstr. 10, 04103, Leipzig, Germany. maria.strauss@medizin.uni-leipzig.de.
Jazyk: angličtina
Zdroj: European archives of psychiatry and clinical neuroscience [Eur Arch Psychiatry Clin Neurosci] 2024 Feb; Vol. 274 (1), pp. 71-82. Date of Electronic Publication: 2023 Jul 22.
DOI: 10.1007/s00406-023-01652-4
Abstrakt: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation treatment used as an alternative or complementary treatment for various neuropsychiatric disorders, and could be an alternative or add-on therapy to psychostimulants in attention-deficit hyperactivity disorder (ADHD). Previous studies provided some evidence for improvements in cognition and clinical symptoms in pediatric and adult ADHD patients. However, data from multi-center randomized controlled trials (RCTs) for this condition are lacking. Thus, our aim is to evaluate short- and mid-term effects of tDCS in this multi-center, randomized, double blind, and sham-controlled, parallel group clinical trial with a 1:1 randomization ratio. Primary endpoint is the total score of DSM-IV scale of the internationally established Conners' Adult ADHD Rating Scales (German self-report screening version, CAARS-S-SR), at day 14 post-intervention (p.i.) to detect short-term lasting effects analyzed via analyses of covariance (ANCOVAs). In case of significant between-groups differences at day 14 p.i., hierarchically ordered hypotheses on mid-term lasting effects will be investigated by linear mixed models with visit (5 time points), treatment, treatment by visit interaction, and covariates as fixed categorical effects plus a patient-specific visit random effect, using an unstructured covariance structure to model the residual within-patient errors. Positive results of this clinical trial will expand the treatment options for adult ADHD patients with tDCS and provide an alternative or add-on therapy to psychostimulants with a low risk for side effects.Trial Registration The trial was registered on July 29, 2022 in the German Clinical Trials Register (DRKS00028148).
(© 2023. The Author(s).)
Databáze: MEDLINE
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