Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in Children

January 11, 2026 updated by: Shanghai Children's Medical Center
This study aims to establish a novel personalized closed-loop NiBS/TMS therapeutic strategy and clinical protocol for children with Tic Disorders (TDs) through a series of scientific investigations. Additionally, it seeks to elucidate the underlying neural circuit mechanisms, enhance the therapeutic efficacy of TMS in pediatric TDs, and achieve precision neuromodulation for children with TDs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center，School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1: Children and adolescents aged 5 to 18 years

    2: Meets DSM-5 diagnostic criteria for Tic Disorders (TDs) with normal EEG findings

    3: No prior treatment received for TDs

    4: Full-scale intelligence quotient (FIQ) ≥70 on the Wechsler Intelligence Scale for Children-Revised (WISC-R)

Exclusion Criteria:

  • 1: WISC-R Full-Scale Intelligence Quotient (FIQ) <70

    2: Presence of metal implants in the body ，Non-right-handedness

    3: Head movement (HM) >2mm during fMRI scanning, including both translational movement (TM) and rotational movement (RM)

    4: Any other neurological or psychiatric conditions, including but not limited to autism spectrum disorder (ASD), epilepsy, obsessive-compulsive disorder (OCD), etc

    5: Previous head trauma ，Neurological diseases ，Major systemic illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The child will use a transcranial magnetic stimulator model ZL-N-010 to stimulate preselected targets located in the prefrontal lobe, bilateral temporal lobes, and parietal lobe. The child may rest as needed during the treatment process. Each TMS session lasts approximately 30 minutes. A total of 10 sessions will be administered. They will also use general behavioral therapy.
Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) will be administered to the child using a ZL-N-010 model device, targeting predefined sites in the prefrontal, bilateral temporal, and parietal lobes.
Behavioral: general behavioral therapy
Behavioral interventions include avoiding screen time, parental avoidance of scolding or corporal punishment, and steering clear of activities or emotional stimuli that may exacerbate symptoms.
Placebo Comparator: Sham-Controlled Observation Group
The child will receive sham stimulation and general behavioral therapy.
Behavioral: general behavioral therapy
Behavioral interventions include avoiding screen time, parental avoidance of scolding or corporal punishment, and steering clear of activities or emotional stimuli that may exacerbate symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tic Severity
Time Frame: 10 weeks
The severity of the child's clinical tic symptoms assessed via the Yale Global Tic Severity Scale.
10 weeks
Changes in brain region activation intensity and resting-state connectivity before and after treatment.
Time Frame: 10 weeks
Based on fMRI imaging, changes in brain region activation intensity (BOLD signals) and resting-state functional connectivity (FC) before and after treatment were compared.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY202504140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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