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
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10316/105505 https://doi.org/10.1186/s13063-021-05172-1 |
Resumo: | 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 followup (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. Trial registration: The trial is registered with the German Clinical Trials Register (DRKS), DRKS00014732. Registered on 15 August 2018. Protocol version: This study protocol refers to protocol version 1.2 from 24 May 2019. |
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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 trialAutism spectrum disorderTranscranial direct current stimulationtDCS, Randomized controlled trialTempo-parietal junctionAdolescentBrainChildClinical Trials, Phase II as TopicDouble-Blind MethodHumansRandomized Controlled Trials as TopicTreatment OutcomeAutism Spectrum DisorderTranscranial Direct Current StimulationAutism 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 followup (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. Trial registration: The trial is registered with the German Clinical Trials Register (DRKS), DRKS00014732. Registered on 15 August 2018. Protocol version: This study protocol refers to protocol version 1.2 from 24 May 2019.Springer Nature2021-04-06info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10316/105505http://hdl.handle.net/10316/105505https://doi.org/10.1186/s13063-021-05172-1eng1745-6215Luckhardt, ChristinaSchütz, MagdalenaMühlherr, AndreasMössinger, HannahBoxhoorn, SaraDempfle, AstridSalvador, RicardoRuffini, GiulioPereira, Helena C.Castelo-Branco, MiguelLatinus, MarianneBonnet-Brilhault, FrédériqueSiemann, JuliaSiniatchkin, MichaelEcker, ChristineFreitag, Christine M.info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-03-03T09:56:11Zoai:estudogeral.uc.pt:10316/105505Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:22:04.038820Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
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 |
title |
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 |
spellingShingle |
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 Luckhardt, Christina Autism spectrum disorder Transcranial direct current stimulation tDCS, Randomized controlled trial Tempo-parietal junction Adolescent Brain Child Clinical Trials, Phase II as Topic Double-Blind Method Humans Randomized Controlled Trials as Topic Treatment Outcome Autism Spectrum Disorder Transcranial Direct Current Stimulation |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
author |
Luckhardt, Christina |
author_facet |
Luckhardt, Christina Schütz, Magdalena Mühlherr, Andreas Mössinger, Hannah Boxhoorn, Sara Dempfle, Astrid Salvador, Ricardo Ruffini, Giulio Pereira, Helena C. Castelo-Branco, Miguel Latinus, Marianne Bonnet-Brilhault, Frédérique Siemann, Julia Siniatchkin, Michael Ecker, Christine Freitag, Christine M. |
author_role |
author |
author2 |
Schütz, Magdalena Mühlherr, Andreas Mössinger, Hannah Boxhoorn, Sara Dempfle, Astrid Salvador, Ricardo Ruffini, Giulio Pereira, Helena C. Castelo-Branco, Miguel Latinus, Marianne Bonnet-Brilhault, Frédérique Siemann, Julia Siniatchkin, Michael Ecker, Christine Freitag, Christine M. |
author2_role |
author author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Luckhardt, Christina Schütz, Magdalena Mühlherr, Andreas Mössinger, Hannah Boxhoorn, Sara Dempfle, Astrid Salvador, Ricardo Ruffini, Giulio Pereira, Helena C. Castelo-Branco, Miguel Latinus, Marianne Bonnet-Brilhault, Frédérique Siemann, Julia Siniatchkin, Michael Ecker, Christine Freitag, Christine M. |
dc.subject.por.fl_str_mv |
Autism spectrum disorder Transcranial direct current stimulation tDCS, Randomized controlled trial Tempo-parietal junction Adolescent Brain Child Clinical Trials, Phase II as Topic Double-Blind Method Humans Randomized Controlled Trials as Topic Treatment Outcome Autism Spectrum Disorder Transcranial Direct Current Stimulation |
topic |
Autism spectrum disorder Transcranial direct current stimulation tDCS, Randomized controlled trial Tempo-parietal junction Adolescent Brain Child Clinical Trials, Phase II as Topic Double-Blind Method Humans Randomized Controlled Trials as Topic Treatment Outcome Autism Spectrum Disorder Transcranial Direct Current Stimulation |
description |
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 followup (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. Trial registration: The trial is registered with the German Clinical Trials Register (DRKS), DRKS00014732. Registered on 15 August 2018. Protocol version: This study protocol refers to protocol version 1.2 from 24 May 2019. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-04-06 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10316/105505 http://hdl.handle.net/10316/105505 https://doi.org/10.1186/s13063-021-05172-1 |
url |
http://hdl.handle.net/10316/105505 https://doi.org/10.1186/s13063-021-05172-1 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
1745-6215 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
Springer Nature |
publisher.none.fl_str_mv |
Springer Nature |
dc.source.none.fl_str_mv |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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