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

Holland Bloorview Kids Rehabilitation Hospital

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Device: Sham at-home tDCS; Device: At-home transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06129058

ASDR02

Details and patient eligibility

About

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..

Full 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..

Enrollment: 20 estimated patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

tDCS

Experimental group

Description:

active tDCS

Treatment:

Device: At-home transcranial direct current stimulation (tDCS)

Sham

Sham Comparator group

Description:

sham tDCS

Treatment:

Device: Sham at-home tDCS