Brain Stimulation and Sensory Integration in Children With ASD

NCT07182331 | Enrolling By Invitation

• 2 other identifiers: 2.2.6.1BR27198099
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Transcranial Magnetic Stimulation; Theta Burst Stimulation; Pediatric Neurostimulation; Neurodevelopmental Disorders; Multimodal Biomarkers; Electrophysiology; Functional Near-Infrared Spectroscopy; Magnetic Resonance Imaging; Genetic Markers; Randomized Controlled Trial; Sham-Controlled Trial; Child Neuropsychology; Autism Spectrum Disorder; Sensory Processing; Audiovisual Integration; Temporal Binding Window; Sound-Induced Flash Illusion; Temporal Perception

Outcome Measures

Primary Outcomes (1)

• Change in Temporal Binding Window (TBW) Width Measured Using the Sound-Induced Flash Illusion (SIFI) Task

  The TBW reflects the time interval within which auditory and visual stimuli are integrated as a single percept. It is assessed by computing the proportion of illusion-consistent responses across varying stimulus onset asynchronies in the SIFI task. A reduction in TBW width, measured in milliseconds (ms) following stimulation indicates improved multisensory temporal precision.

  Baseline and up to 7 days after the final TMS session.

Secondary Outcomes (4)

• Change in Sensory Processing Profile (Short Sensory Profile, SSP)

  Baseline and up to 7 days after the final TMS session.

• Change in Autism Symptom Severity (Autism Treatment Evaluation Checklist, ATEC)

  Baseline and up to 7 days after the final TMS session.

• Change in Resting-State Prefrontal Activity - Mean Oxygenation (fNIRS)

  Baseline and up to 7 days after the final TMS session.

• Change in Resting-State Prefrontal Activity - Functional Connectivity (fNIRS)

  Baseline and up to 7 days after the final TMS session.

Other Outcomes (3)

• Correlation of Cortical Thickness (MRI) with Change in TBW Width (SIFI)

  MRI obtained once at baseline.

• Correlation of Cortical Volume (MRI) with Change in TBW Width (SIFI)

  MRI obtained once at baseline.

• Correlation of Genetic Variant Frequencies with Change in TBW Width (SIFI)

  Saliva samples collected once at baseline.

Study Arms (2)

Active cTBS to Bilateral DLPFC

EXPERIMENTAL

Participants receive active continuous theta burst stimulation (cTBS) targeting both the left and right dorsolateral prefrontal cortex (DLPFC) during each session. Stimulation is delivered consecutively to both hemispheres using a standard cTBS protocol: 600 pulses per side (triplet bursts at 50 Hz, repeated at 5 Hz), with each hemisphere receiving stimulation over approximately 40 seconds, at 80% of the individual's active motor threshold. A total of 10 bilateral sessions are delivered over two weeks.

Device: Continuous Theta Burst Stimulation to Bilateral DLPFC

Sham cTBS to Bilateral DLPFC

SHAM COMPARATOR

Participants receive sham stimulation to both the left and right DLPFC during each session. Procedures mimic the active condition, including coil placement, session duration, and auditory cues, but no effective magnetic pulses are delivered. Each participant completes 10 bilateral sham sessions over two weeks. The protocol maintains blinding to control for placebo effects and procedural expectations.

Device: Sham Continuous Theta Burst Stimulation

Interventions

Continuous Theta Burst Stimulation to Bilateral DLPFC DEVICE

Participants receive continuous theta burst stimulation (cTBS) targeting both the left and right dorsolateral prefrontal cortex (DLPFC) during each session. Each hemisphere is stimulated with 600 pulses (triplets at 50 Hz repeated at 5 Hz) over \~40 seconds, at 80% of the individual's active motor threshold. Sessions are administered once daily over 10 treatment days.

Also known as: cTBS

Active cTBS to Bilateral DLPFC

Sham Continuous Theta Burst Stimulation DEVICE

Participants receive sham continuous theta burst stimulation (cTBS) to both the left and right dorsolateral prefrontal cortex (DLPFC) using a placebo coil that mimics the auditory and tactile sensations of real stimulation but does not produce a magnetic field capable of affecting brain activity. Coil positioning, session timing, and procedure match the active cTBS protocol, including consecutive stimulation to both hemispheres. Both participants and TMS technicians wear earplugs to mask subtle sound differences between active and sham coils. This setup maintains participant and operator blinding and controls for placebo-related effects.

Also known as: Sham cTBS

Sham cTBS to Bilateral DLPFC

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurolab Plus: lead
• Al-Farabi Kazakh National University (KazNU): collaborator

Study Sites (2)

Neurolab Plus

Almaty, 050000, Kazakhstan

Location

Non-profit joint-stock company "Al-Farabi Kazakh National University"

Almaty, 050040, Kazakhstan

Location

Related Publications (14)

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MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors are all blinded to group assignment (active vs. sham TMS). The sham condition mimics the sound and sensation of stimulation without delivering active magnetic pulses, using an identical setup. Randomization and group codes are maintained by an independent administrator and not revealed until after final data analysis. Blinding is used to reduce bias in behavioral, neurophysiological, and questionnaire-based outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 19, 2025
• Study Start: August 25, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data will be made available within 12 months following publication of the main study results and will remain available for at least 5 years thereafter.
• Access Criteria: Data will be accessible to qualified researchers at academic or medical institutions upon submission of a justified request. Each request will be reviewed by the study steering committee. Approved researchers will sign a data use agreement to ensure compliance with ethical standards, including prohibiting any attempt to re-identify participants. Data will be distributed via a secure repository.

Locations

KA (2)