Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-09-30

Brief Summary

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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..

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Detailed Description

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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..

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized sham-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants and outcomes assessor will be blind to tDCS or sham condition.

Study Groups

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tDCS

active tDCS

Group Type EXPERIMENTAL

At-home transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

30 minutes session 5 days/week for 3 weeks.

Sham

sham tDCS

Group Type SHAM_COMPARATOR

Sham at-home tDCS

Intervention Type DEVICE

30 minutes session 5 days/week for 3 weeks.

Interventions

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At-home transcranial direct current stimulation (tDCS)

30 minutes session 5 days/week for 3 weeks.

Intervention Type DEVICE

Sham at-home tDCS

30 minutes session 5 days/week for 3 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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.)

Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No