Autism Spectrum Disorder
Conditions
Keywords
tDCS, MRI, brain stimulation
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..
Interventions
DEVICEAt-home transcranial direct current stimulation (tDCS)
30 minutes session 5 days/week for 3 weeks.
DEVICESham at-home tDCS
30 minutes session 5 days/week for 3 weeks.
Sponsors
Holland Bloorview Kids Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants and outcomes assessor will be blind to tDCS or sham condition.
Intervention model description
Randomized sham-controlled
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | weeks 1-18 | Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate |
| Attrition | weeks 1-18 | Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments). |
| Adherence | weeks 1-18 | 90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions) |
| Blinding | 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
| Measure | Time frame | Description |
|---|---|---|
| Inhibitory control | 0 weeks, 6 weeks, 18 weeks | change in Go/No Task Response Time |
| 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) |
| 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 |
Countries
Canada
Contacts
Primary ContactDeryk Beal, PhD
Outcome results
None listed