NCT06129058

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..

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1.9 years

First QC Date

November 8, 2023

Last Update Submit

July 29, 2024

Conditions

Autism Spectrum Disorder

Keywords

tDCSMRIbrain stimulation

Outcome Measures

Primary Outcomes (4)

  • Recruitment

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

    weeks 1-18

  • Attrition

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

    weeks 1-18

  • Adherence

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

    weeks 1-18

  • Blinding

    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)

    weeks 1-18

Secondary Outcomes (3)

  • Magnetic Resonance Imaging (MRI)

    0 weeks, 6 weeks, 18 weeks

  • Inhibitory control

    0 weeks, 6 weeks, 18 weeks

  • Overall Clinical Change

    0 weeks, 6 weeks, 18 weeks

Study Arms (2)

tDCS

EXPERIMENTAL

active tDCS

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

Sham

SHAM COMPARATOR

sham tDCS

Device: Sham at-home tDCS

Interventions

At-home transcranial direct current stimulation (tDCS)DEVICE

30 minutes session 5 days/week for 3 weeks.

tDCS
Sham at-home tDCSDEVICE

30 minutes session 5 days/week for 3 weeks.

Sham

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges
  • Able to participate in tDCS

You may not qualify if:

  • Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)
  • Co-existing neurological conditions (epilepsy, stroke, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hosptail

Toronto, Ontario, M4G1R5, Canada

RECRUITING

Related Publications (1)

  • Abbo N, Mitchell T, Tonekaboni SH, Anagnostou E, Andrade BF, Thorpe K, Beal DS. Feasibility and usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2025 Apr 29;11(1):57. doi: 10.1186/s40814-025-01650-4.

    PMID: 40301914DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Deryk Beal, PhD

CONTACT

416-425-6220dbeal@hollandbloorview.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants and outcomes assessor will be blind to tDCS or sham condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized sham-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

October 20, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)