NCT07182331Enrolling by invitation
Brain Stimulation and Sensory Integration in Children With ASD
Effects of cTBS on Sensory Integration in Children With Autism Spectrum Disorder: A Randomized, Sham-Controlled Study Integrating Genetic Markers, MRI, fNIRS, and Temporal Binding Tasks
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 25 Aug 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Neurolab Plus
- Diseases
- Autism
- NCT number
- NCT07182331
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 25 Aug 2025 to the primary completion date, Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of metal implants, devices, or foreign bodies in or near the head (except dental fillings) that are contraindicated for TMS or MRI.
Other illness
- History of epilepsy, seizures, or abnormal EEG suggestive of seizure risk.
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurolab Plus Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Unknown status |
| Non-profit joint-stock company "Al-Farabi Kazakh National University" Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.