Recruiting
Phase 2

tDCS

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT06129058

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

Interventions

At-home transcranial direct current stimulation (tDCS)

Sham at-home tDCS

Study Details

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..

Conditions

Autism Spectrum Disorder

Study ID

NCT06129058

Start date

Oct 20, 2023

Status verified date

Jul, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges
  • Able to participate in tDCS

Exclusion Criteria:

  • Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)
  • Co-existing neurological conditions (epilepsy, stroke, etc.)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tDCS

active tDCS

sham comparator: Sham

sham tDCS

Interventions

At-home transcranial direct current stimulation (tDCS)

30 minutes session 5 days/week for 3 weeks.

Sham at-home tDCS

30 minutes session 5 days/week for 3 weeks.

Primary outcome measure

  • Recruitment [ Time Frame: weeks 1-18 ]
  • Attrition [ Time Frame: weeks 1-18 ]
  • Adherence [ Time Frame: weeks 1-18 ]
  • Blinding [ Time Frame: weeks 1-18 ]

Central Contacts and Locations

Central contacts

Deryk Beal, PhD

416-425-6220dbeal@hollandbloorview.ca

Locations

Holland Bloorview Kids Rehabilitation Hosptail

Recruiting

Toronto, Ontario, Canada, M4G1R5

Contacts

Deryk Beal, PhD

416-425-6220dbeal@hollandbloorview.ca

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Jul 30, 2024

Last verified

Jul, 2024

Keywords

  • tDCS
  • MRI
  • brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2024-07-30.