Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645587
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Targeting Repetitive Behaviors in Autism Spectrum Disorder Via Transcranial Direct Current Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repetitive behaviors RBs are a prevalent feature of Autism Spectrum Disorder ASD There are two groups of RBs lower-order eg motor stereotypies and higher-order RBs eg restricted interests linked to sensory-motor and the associative loops respectively To date treatment options for RBs are very limited High-definition transcranial direct current stimulation HD-tDCS may be effective in reducing the impact of RBs in children with ASD by targeting the associated brain alterations Moreover the high focality of HD-tDCS will help the investigators to disentangle the relative contribution of different brain loops namely sensory-motor and the associative loops into RBs subtypes The investigators will also study the electrophysiological patterns associated to behavioral changes after the application of HD-tDCS
Detailed Description:
The experimental design will be the following randomized three-arm between subject double blind and placebo-controlled
Children and adolescents with ASD will be selected and randomly assigned to three groups 1 Active high-definition tDCS HD-tDCS over pre-SMA 2 Active high-definition tDCS HD-tDCS left DLPFC 3 Sham high-definition tDCS HD-tDCS
In this project the investigators will work to understand whether a brain-based intervention with the use of HD-tDCS can enhance RBs in individuals with ASD
The protocol will allow the investigators to
1 Test if Active high-definition tDCS HD-tDCS compared to sham HD-tDCS will contribute in reducing RBs
2 Test if HD-tDCS over pre-SMA cortex will decrease lower-order RBs while HD-tDCS over dlPFC will decrease higher-order RBs
3 Test if the Active Groups will significantly improve in the remaining psychological measures compared to the Sham Group
4 Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in neuropsychological and electroencephalographic EEG connectivity measures
5 Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in the remaining psychological measures and parental stress
The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ASD
Children and adolescents with ASD will be selected and randomly assigned to three groups 1 Active high-definition tDCS HD-tDCS over pre-SMA 2 Active high-definition tDCS HD-tDCS left DLPFC 3 Sham high-definition tDCS HD-tDCS
In this project the investigators will work to understand whether a brain-based intervention with the use of HD-tDCS can enhance RBs in individuals with ASD
The protocol will allow the investigators to
1 Test if Active high-definition tDCS HD-tDCS compared to sham HD-tDCS will contribute in reducing RBs
2 Test if HD-tDCS over pre-SMA cortex will decrease lower-order RBs while HD-tDCS over dlPFC will decrease higher-order RBs
3 Test if the Active Groups will significantly improve in the remaining psychological measures compared to the Sham Group
4 Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in neuropsychological and electroencephalographic EEG connectivity measures
5 Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in the remaining psychological measures and parental stress
The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ASD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None