Brain Stimulation and Sensory Integration in Children With ASD (NCT07182331) | Clinical Trial Compass
By InvitationNot Applicable
Brain Stimulation and Sensory Integration in Children With ASD
Kazakhstan40 participantsStarted 2025-08-25
Plain-language summary
The goal of this clinical trial is to find out if brain stimulation can help improve sensory integration in children ages 6 to 12 with autism spectrum disorder (ASD). The main questions it aims to answer are:
Does brain stimulation using continuous theta-burst stimulation (cTBS) on bilateral dorsolateral prefrontal cortex (DLPFC) improve how children process sights and sounds together? Can brain functioning, structure, and genetics help predict who responds best to this treatment?
Researchers will compare the results of the randomly assigned active brain stimulation to sham (inactive) stimulation groups to see if the treatment works.
Participants will:
Receive 10 sessions of either active or sham cTBS over 2 weeks Complete a sensory task involving flashes and beeps before and after stimulation Take part in brain scans, namely magnetic resonance imaging (MRI) and functional near-infrared spectroscopy (fNIRS), and provide a saliva sample for genetic testing
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 6-12 years at the time of enrollment.
* Clinical diagnosis of Autism Spectrum Disorder (ASD) confirmed using the Autism Diagnostic Interview-Revised (ADI-R).
* Intelligence quotient (IQ) ≥ 70 as measured by the General Ability Index (GAI) from the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
* Ability to understand and follow simple instructions for behavioral tasks and stimulation procedures.
* Stable medication regimen (if any) for at least 4 weeks before the start of the study.
* Written informed consent from a parent or legal guardian, and assent from the child when appropriate.
Exclusion Criteria:
* History of epilepsy, seizures, or abnormal EEG suggestive of seizure risk.
* Presence of metal implants, devices, or foreign bodies in or near the head (except dental fillings) that are contraindicated for TMS or MRI.
* Serious neurological disorders other than ASD (e.g., cerebral palsy, brain injury, neurodegenerative disease).
* Severe psychiatric disorders requiring hospitalization or urgent intervention.
* Current or past history of significant head trauma with loss of consciousness \> 5 minutes.
* Uncorrected hearing or vision problems that could interfere with task performance.
* Inability to tolerate sitting still for 15-20 minutes.
* Participation in another interventional clinical trial within the past 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Temporal Binding Window (TBW) Width Measured Using the Sound-Induced Flash Illusion (SIFI) Task
Timeframe: Baseline and up to 7 days after the final TMS session.