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NCT Number: NCT06129058

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

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..

Recruiting

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Holland Bloorview Kids Rehabilitation Hosptail

Toronto, Ontario, M4G1R5, Canada

Location status: Recruiting

Location contact

Deryk Beal, PhD

CONTACT

[email protected]

416-425-6220 ext. 3582

Evdokia Anagnostou, MD

SUB_INVESTIGATOR

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

At-home transcranial direct current stimulation (tDCS)

Device

30 minutes session 5 days/week for 3 weeks.

Sham at-home tDCS

Device

30 minutes session 5 days/week for 3 weeks.

Primary outcomes

  1. Recruitment

    Time frame: weeks 1-18

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

  2. Attrition

    Time frame: weeks 1-18

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

  3. Adherence

    Time frame: weeks 1-18

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

  4. Blinding

    Time frame: weeks 1-18

    Blinding of participants and their parents/caregivers and required study team using a Blinding Questionnaire indicating the perceived group membershipmembers will be assessed using a Blinding Questionnaire indicating the perceived group membership (tDCS/Sham)

Secondary outcomes

  1. Magnetic Resonance Imaging (MRI)

    Time frame: 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

    Time frame: 0 weeks, 6 weeks, 18 weeks

    change in Go/No Task Response Time

  3. Overall Clinical Change

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Deryk Beal, PhD

CONTACT

[email protected]

416-425-6220 ext. 3582

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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