Autism Spectrum DisorderPhase 2NCT06129058
Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
A Phase 2 study testing At-home transcranial direct current stimulation (tDCS) in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- At-home transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2023to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges
- Able to participate in tDCS
Who cannot join
- Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)
- Co-existing neurological conditions (epilepsy, stroke, etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Holland Bloorview Kids Rehabilitation Hosptail
Toronto, Ontario, M4G1R5
Deryk Beal, PhD, 416-425-6220 ext. 3582, dbeal@hollandbloorview.ca
Evdokia Anagnostou, MD
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). 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..
Read the 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..
- Conditions
- Autism Spectrum Disorder
- Being tested
- At-home transcranial direct current stimulation (tDCS), Sham at-home tDCS
- Keywords
- tDCS, MRI, brain stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home transcranial direct current stimulation (tDCS)Device
30 minutes session 5 days/week for 3 weeks.
Sham at-home tDCSDevice
30 minutes session 5 days/week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | active tDCS Receives: Device: At-home transcranial direct current stimulation (tDCS) |
| Sham | Sham comparator | sham tDCS Receives: Device: Sham at-home tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Measured: weeks 1-18
Attrition
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Measured: weeks 1-18
Adherence
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
Measured: 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)
Measured: weeks 1-18
Secondary outcomes (3)
Magnetic Resonance Imaging (MRI)
Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal
Measured: 0 weeks, 6 weeks, 18 weeks
Inhibitory control
change in Go/No Task Response Time
Measured: 0 weeks, 6 weeks, 18 weeks
Overall Clinical Change
Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)
Measured: 0 weeks, 6 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start20 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized sham-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129058
- Sponsor's protocol ID
- ASDR02
- Status last verified
- Jul 2024
- First submitted
- 8 Nov 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40301914
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT06129058
- Acronym / sponsor ID
- ASDR02
- Conditions
- Autism Spectrum Disorder
- Keywords
- tDCS, MRI, brain stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized sham-controlled
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: At-home transcranial direct current stimulation (tDCS)active tDCS |
| Sham | Sham comparator | Device: Sham at-home tDCSsham tDCS |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges
- Able to participate in tDCS
Key exclusion criteria (2 listed)
- Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)
- Co-existing neurological conditions (epilepsy, stroke, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-home transcranial direct current stimulation (tDCS)30 minutes session 5 days/week for 3 weeks. | Device | tDCS |
| Sham at-home tDCS30 minutes session 5 days/week for 3 weeks. | Device | Sham |
Primary outcome
Recruitment
Time frame: weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Attrition
Time frame: weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Adherence
Time frame: weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
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)
3 secondary outcomes
Magnetic Resonance Imaging (MRI)
Time frame: 0 weeks, 6 weeks, 18 weeks
Inhibitory control
Time frame: 0 weeks, 6 weeks, 18 weeks
Overall Clinical Change
Time frame: 0 weeks, 6 weeks, 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 40301914Abbo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing At-home transcranial direct current stimulation (tDCS) in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deryk Beal, PhD (416-425-6220 ext. 3582, dbeal@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: weeks 1-18). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.