Mauche, Nicole
Ulke, Christine
Huang, Jue
Franke, Annegret
Bogatsch, Holger
Ethofer, Thomas
Grimm, Oliver
Frodl, Thomas
Hoffmann, Knut
Juckel, Georg
Kittel-Schneider, Sarah
Mehren, Aylin
Philipsen, Alexandra
Plewnia, Christian
Reif, Andreas
Ziegler, Georg C.
Strauß, Maria http://orcid.org/0000-0002-0072-2199
Clinical trials referenced in this document:
Documents that mention this clinical trial
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)
https://doi.org/10.1007/s00406-023-01652-4
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (STR 1514/3-1)
Universitätsklinikum Leipzig
Article History
Received: 23 May 2023
Accepted: 7 July 2023
First Online: 22 July 2023
Declarations
:
: AR has served on advisory boards and has received speaker’s honoraria from Medice and Shire/Takeda. SKS has received author’s and speaker’s honoraria from Takeda and Medice Arzneimittel Pütter GmbH&Co.KG in the past 3 years. MS has received speaker’s fees from MEDICE Arzneimittel Pütter GmbH & Co. KG and Takeda and was an advisory board member for Takeda in the past 3 years. AP has received research funding from the Federal Ministry of Research and Education, the EU (Horizon2020, ITEA), the NIHR, the German Research Foundation, the State North Rhine Westphalia and Medice and has been a consultant for Takeda, Medice, Boehringer, Janssen-Cilag and was a supervisor for Behavioral Therapy and DBT supervisor, articles/books on ADHD published by Elsevier, Hogrefe, Schattauer, Thieme, Oxford Press, Kohlhammer, Springer and Medizinisch Wissenschaftliche Verlagsgesellschaft. The other authors do not report any possible conflicts of interest.
: This trial will be conducted in accordance with the International Standard ISO 14155: 2021. All persons participating in the conduct of the study commit themselves to adhere to the Declaration of Helsinki of the World Medical Association (WMA), as well as all pertinent national laws and the ISO 14155: 2021 Good Clinical Practice for Medical Devices. The trial follows the medical device regulation (MDR) article 82 and MPDG § 47 (1–2). Thus, approval has to be obtained from the responsible ethics committee and a notification has to be filed to the competent authority, i.e., Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). The Ethics Committee of the Faculty of Medicine of the University of Leipzig (DE-22-00014008) and the responsible Ethics Committees of the participating centers have approved the protocol, patient information, and consent form of this clinical trial. All persons gave their written informed consent prior to their inclusion in the study.