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RecruitingNCT07351955Updated Jan 20, 2026

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

An interventional study of Transcranial Magnetic Stimulation and general behavioral therapy in Tic Disorders, sponsored by Shanghai Children's Medical Center. Recruiting at 1 site in China. Open to participants aged 5 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Shanghai Children's Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jun 2025, registered Jan 2026).
  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
5 Months to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tic Disorders

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Keywords

  • Transcranial Magnetic Stimulation
03

In context

Tic Disorders

102 studies on the registry are indexed under Tic Disorders; 26 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 83 interventional studies indexed under Tic Disorders.

Browse Tic Disorders studies →

Lead sponsor

Shanghai Children's Medical Center is the lead sponsor of 38 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1: Children and adolescents aged 5 to 18 years

    2: Meets 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

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Behavioral: general behavioral therapy

  • Placebo comparator
    Sham-Controlled Observation Group

    The child will receive sham stimulation and general behavioral therapy.

    Behavioral: general behavioral therapy

Interventions

  • DeviceTranscranial 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.

  • Behavioralgeneral 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.

06

What researchers measure

Primary outcomes

  1. Tic Severity

    The severity of the child's clinical tic symptoms assessed via the Yale Global Tic Severity Scale.

    Time frame: 10 weeks

  2. Changes in brain region activation intensity and resting-state connectivity before and after treatment.

    Based on fMRI imaging, changes in brain region activation intensity (BOLD signals) and resting-state functional connectivity (FC) before and after treatment were compared.

    Time frame: 10 weeks

07

Study locations

1 of 1 sites recruiting
  • Shanghai Children's Medical Center,School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai Municipality 200127, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07351955
Lead sponsor
Shanghai Children's Medical Center
Responsible party
Sponsor
First posted
Jan 20, 2026
Start date
Jun 1, 2025
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Jan 20, 2026

Study contacts

Jun Ma, M.D.
Contact
majun@shsmu.edu.cn
13917230745

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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