Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129058
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-11-08
Brief Title:
Home-based Transcranial Direct Current Stimulation tDCS to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder ASD
Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Organization:
Holland Bloorview Kids Rehabilitation Hospital
Study Overview
Official Title:
Home-based Transcranial Direct Current Stimulation tDCS to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder ASD
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transcranial direct current stimulation tDCS is a form of non-invasive brain stimulation that can be delivered in a home setting It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder ASD Children and youth with ASD will be randomized to At-home tDCS or sham control stimulation for 3 weeks We will measure the effect of At-home tDCS on the brain mechanisms and clinical measures of social communication and self-regulation
Detailed Description:
Transcranial direct current stimulation tDCS is a form of non-invasive brain stimulation that can be delivered in a home setting It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder ASD Previous studies have been limited by small and poorly represented samples lack of experimental control insufficient follow-up periods inadequate blinding and the absence of neural outcome measures Our project will collect pilot data on the effects of home-based tDCS on reducing disruptive behaviours in youth with ASD in order to inform the design of a follow-up full-scale clinical trial We will recruit youth with ASD who experience clinically significant difficulties with social communication and self-regulation Participants will be randomized to tDCS or sham control stimulation for 3 weeks We will measure the effect of tDCS on the brain mechanisms and clinical measures of social communication and self-regulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None