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pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD

NCT06031948 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-11

No results posted yet for this study

Summary

This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).

Conditions

Interventions

DEVICE

sham iTBS

Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

DEVICE

sham iTBS

Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

DEVICE

active iTBS

Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

DEVICE

active iTBS

Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    collaborator OTHER

  • 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
30 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-08-01
Completion
2025-01-01

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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 NCT06031948 on ClinicalTrials.gov