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NCT Number: NCT07351955

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

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.

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Key information

Conditions

Tic Disorders Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodevelopmental Disorders

Age range

5 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Children's Medical Center，School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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.

general behavioral therapy

Behavioral

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.

Primary outcomes

  1. Tic Severity

    Time frame: 10 weeks

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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Ma, M.D.

CONTACT

[email protected]

13917230745

Sponsors and collaborators

Lead sponsor

Shanghai Children's Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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