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Phase-IIa randomized, double-blind, sham-controlled, parallel group trial on anodal transcranial direct current stimulation (tDCS) over the left and right tempo-parietal junction in autism spectrum disorder-StimAT: study protocol for a clinical trial

  • Background: Autism spectrum disorder (ASD) is characterized by impaired social communication and interaction, and stereotyped, repetitive behaviour and sensory interests. To date, there is no effective medication that can improve social communication and interaction in ASD, and effect sizes of behaviour-based psychotherapy remain in the low to medium range. Consequently, there is a clear need for new treatment options. ASD is associated with altered activation and connectivity patterns in brain areas which process social information. Transcranial direct current stimulation (tDCS) is a technique that applies a weak electrical current to the brain in order to modulate neural excitability and alter connectivity. Combined with specific cognitive tasks, it allows to facilitate and consolidate the respective training effects. Therefore, application of tDCS in brain areas relevant to social cognition in combination with a specific cognitive training is a promising treatment approach for ASD. Methods: A phase-IIa pilot randomized, double-blind, sham-controlled, parallel-group clinical study is presented, which aims at investigating if 10 days of 20-min multi-channel tDCS stimulation of the bilateral tempo-parietal junction (TPJ) at 2.0 mA in combination with a computer-based cognitive training on perspective taking, intention and emotion understanding, can improve social cognitive abilities in children and adolescents with ASD. The main objectives are to describe the change in parent-rated social responsiveness from baseline (within 1 week before first stimulation) to post-intervention (within 7 days after last stimulation) and to monitor safety and tolerability of the intervention. Secondary objectives include the evaluation of change in parent-rated social responsiveness at follow-up (4 weeks after end of intervention), change in other ASD core symptoms and psychopathology, social cognitive abilities and neural functioning post-intervention and at follow-up in order to explore underlying neural and cognitive mechanisms. Discussion: If shown, positive results regarding change in parent-rated social cognition and favourable safety and tolerability of the intervention will confirm tDCS as a promising treatment for ASD core-symptoms. This may be a first step in establishing a new and cost-efficient intervention for individuals with ASD.

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Author:Christina LuckhardtORCiDGND, Magdalena SchützORCiDGND, Andreas MühlherrGND, Hannah MössingerORCiD, Sara BoxhoornORCiDGND, Astrid DempfleORCiDGND, Ricardo SalvadorORCiD, Giulio RuffiniORCiD, Helena C. Pereira, Miguel Castelo-BrancoGND, Marianne LatinusORCiD, Frédérique Bonnet-BrilhaultORCiD, Julia SiemannORCiD, Michael SiniatchkinORCiDGND, Christine EckerORCiD, Christine M. FreitagORCiDGND
URN:urn:nbn:de:hebis:30:3-636462
DOI:https://doi.org/10.1186/s13063-021-05172-1
ISSN:1745-6215
ISSN:1468-6694
Parent Title (English):Trials
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Language:English
Date of Publication (online):2021/04/06
Date of first Publication:2021/04/06
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2022/08/23
Tag:Autism spectrum disorder; Randomized controlled trial; Tempo-parietal junction; Transcranial direct current stimulation; tDCS
Volume:22.2021
Article Number:248
Page Number:16
First Page:1
Last Page:16
Note:
This trial is a part of the EU-Project STIPED (Horizon2020) and is therefore financed through the Grant Agreement No. 731827. This trial does not receive financial support from other funding sources. Open Access funding enabled and organized by Projekt DEAL.
Note:
This study protocol refers to protocol version 1.2 from 24 May 2019.
HeBIS-PPN:502524014
Institutes:Medizin
Dewey Decimal Classification:1 Philosophie und Psychologie / 15 Psychologie / 150 Psychologie
6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0