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1000 Titel
  • 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
1000 Autor/in
  1. Luckhardt, Christina |
  2. Schütz, Magdalena |
  3. Mühlherr, Andreas |
  4. Mössinger, Hannah |
  5. Boxhoorn, Sara |
  6. Dempfle, Astrid |
  7. Salvador, Ricardo |
  8. Ruffini, Giulio |
  9. Pereira, Helena C. |
  10. Castelo-Branco, Miguel |
  11. Latinus, Marianne |
  12. Bonnet-Brilhault, Frédérique |
  13. Siemann, Julia |
  14. Siniatchkin, Michael |
  15. Ecker, Christine |
  16. Freitag, Christine M. |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-04-06
1000 Erschienen in
1000 Quellenangabe
  • 22(1):248
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s13063-021-05172-1 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025356/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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. Protocol version: This study protocol refers to protocol version 1.2 from 24 May 2019.
1000 Sacherschließung
lokal Adolescent [MeSH]
lokal Double-Blind Method [MeSH]
lokal Randomized controlled trial
lokal Study Protocol
lokal Humans [MeSH]
lokal Treatment Outcome [MeSH]
lokal tDCS
lokal Autism spectrum disorder
lokal Brain [MeSH]
lokal Randomized Controlled Trials as Topic [MeSH]
lokal Autism Spectrum Disorder/diagnosis [MeSH]
lokal Transcranial direct current stimulation
lokal Autism Spectrum Disorder/therapy [MeSH]
lokal Transcranial Direct Current Stimulation [MeSH]
lokal Child [MeSH]
lokal Clinical Trials, Phase II as Topic [MeSH]
lokal Tempo-parietal junction
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-5259-7174|https://frl.publisso.de/adhoc/uri/U2Now7x0eiwgTWFnZGFsZW5h|https://frl.publisso.de/adhoc/uri/TcO8aGxoZXJyLCBBbmRyZWFz|https://frl.publisso.de/adhoc/uri/TcO2c3NpbmdlciwgSGFubmFo|https://frl.publisso.de/adhoc/uri/Qm94aG9vcm4sIFNhcmE=|https://frl.publisso.de/adhoc/uri/RGVtcGZsZSwgQXN0cmlk|https://frl.publisso.de/adhoc/uri/U2FsdmFkb3IsIFJpY2FyZG8=|https://frl.publisso.de/adhoc/uri/UnVmZmluaSwgR2l1bGlv|https://frl.publisso.de/adhoc/uri/UGVyZWlyYSwgSGVsZW5hIEMu|https://frl.publisso.de/adhoc/uri/Q2FzdGVsby1CcmFuY28sIE1pZ3VlbA==|https://frl.publisso.de/adhoc/uri/TGF0aW51cywgTWFyaWFubmU=|https://frl.publisso.de/adhoc/uri/Qm9ubmV0LUJyaWxoYXVsdCwgRnLDqWTDqXJpcXVl|https://frl.publisso.de/adhoc/uri/U2llbWFubiwgSnVsaWE=|https://frl.publisso.de/adhoc/uri/U2luaWF0Y2hraW4sIE1pY2hhZWw=|https://frl.publisso.de/adhoc/uri/RWNrZXIsIENocmlzdGluZQ==|https://frl.publisso.de/adhoc/uri/RnJlaXRhZywgQ2hyaXN0aW5lIE0u
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1000 Erstellt am 2023-11-16T14:28:40.143+0100
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