Clinical trial NCT06129058: Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: tDCS
MRI
brain stimulation
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized sham-controlled
Primary purpose: TREATMENT

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..

Eligibility criteria: 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.)

Primary outcomes:
measure: Recruitment
timeFrame: weeks 1-18
measure: Attrition
timeFrame: weeks 1-18
measure: Adherence
timeFrame: weeks 1-18
measure: Blinding
timeFrame: weeks 1-18
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 0 weeks, 6 weeks, 18 weeks
measure: Inhibitory control
timeFrame: 0 weeks, 6 weeks, 18 weeks
measure: Overall Clinical Change
timeFrame: 0 weeks, 6 weeks, 18 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hosptail
state: Ontario
Study officials:
References: