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 (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06129058
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Device: At-home transcranial direct current stimulation (tDCS); Device: Sham at-home tDCS	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized sham-controlledRandomized sham-controlled
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Participants and outcomes assessor will be blind to tDCS or sham condition.
• Primary Purpose: Treatment
• Official Title: Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
• Actual Study Start Date: Oct 20, 2023
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS active tDCS	Device: At-home transcranial direct current stimulation (tDCS); 30 minutes session 5 days/week for 3 weeks.
Sham Comparator: Sham sham tDCS	Device: Sham at-home tDCS; 30 minutes session 5 days/week for 3 weeks.

Outcome Measures

Primary Outcome Measures

1. Recruitment [weeks 1-18]

   Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate

2. Attrition [weeks 1-18]

   Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).

3. Adherence [weeks 1-18]

   90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)

4. Blinding [weeks 1-18]

   Blinding of participants and their parents/caregivers and required study team members will be assessed using a Blinding Questionnaire indicating the perceived group membership

Secondary Outcome Measures

1. Magnetic Resonance Imaging (MRI) [0 weeks, 6 weeks, 18 weeks]

   Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal

2. Inhibitory control [0 weeks, 6 weeks, 18 weeks]

   change in Go/No Task Response Time

3. Overall Clinical Change [0 weeks, 6 weeks, 18 weeks]

   Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Holland Bloorview Kids Rehabilitation Hosptail	Toronto	Ontario	Canada	M4G1R5

Sponsors and Collaborators

• Holland Bloorview Kids Rehabilitation Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT06129058
• Other Study ID Numbers: ASDR02
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Holland Bloorview Kids Rehabilitation Hospital: tDCS; MRI; brain stimulation
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Nov 13, 2023