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pBFS Guided aiTBS Over Language Network for ASD Child

NCT06950437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-11

No results posted yet for this study

Summary

The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.

Conditions

Interventions

DEVICE

active iTBS

Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.

DEVICE

Sham iTBS

Participants will undergo three sham iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.

BEHAVIORAL

speech therapy

Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.

Sponsors & Collaborators

  • Peking University Sixth Hospital

    collaborator OTHER

  • Shanghai Yangzhi Rehabilitation Hospital

    collaborator UNKNOWN

  • Beijing Changping Tianhe Research Institute of Brain Science

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2026-12-31
Completion
2027-06-01

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT06950437 on ClinicalTrials.gov