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Brain Stimulation and Sensory Integration in Children With ASD

NCT07182331 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-19

No results posted yet for this study

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)

Interventions

DEVICE

Continuous Theta Burst Stimulation to Bilateral DLPFC

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.

DEVICE

Sham Continuous Theta Burst Stimulation

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.

Sponsors & Collaborators

  • Al-Farabi Kazakh National University (KazNU)

    collaborator UNKNOWN

  • Neurolab Plus

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07182331 on ClinicalTrials.gov