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pBFS Guided rTMS Over Cognitive Control Network for ASD

NCT06255535 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-02-21

No results posted yet for this study

Summary

The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.

Conditions

Interventions

DEVICE

active iTBS treatment

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 treatment

Participants will undergo three 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.

Sponsors & Collaborators

  • Xi'an TCM Hospital of Encephalopathy

    collaborator UNKNOWN

  • Linyi Hedong Rehabilitation Hospital

    collaborator UNKNOWN

  • Jining Medical University

    collaborator OTHER

  • Fujian Maternity and Child Health Hospital

    collaborator OTHER

  • Fujian Children's Hospital

    collaborator UNKNOWN

  • Hebei Provincial Mental Health Center

    collaborator UNKNOWN

  • Changping Laboratory

    lead OTHER

Principal Investigators

  • Hesheng Liu, Ph.D. · Changping Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-04-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

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 NCT06255535 on ClinicalTrials.gov