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

NCT07351955 | Recruiting

• 1 other identifier: LY202504140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tic Disorders

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• Tic Severity

  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.

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Sham-Controlled Observation Group

PLACEBO COMPARATOR

The child will receive sham stimulation and general behavioral therapy.

Behavioral: general behavioral therapy

Interventions

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.

Intervention Group; Sham-Controlled Observation Group

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.

Intervention Group

Eligibility Criteria

• Age: 5 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• : Children and adolescents aged 5 to 18 years
• : Meets DSM-5 diagnostic criteria for Tic Disorders (TDs) with normal EEG findings
• : No prior treatment received for TDs
• : Full-scale intelligence quotient (FIQ) ≥70 on the Wechsler Intelligence Scale for Children-Revised (WISC-R)

You may not qualify if:

• : WISC-R Full-Scale Intelligence Quotient (FIQ) \<70
• : Presence of metal implants in the body ，Non-right-handedness
• : Head movement (HM) \>2mm during fMRI scanning, including both translational movement (TM) and rotational movement (RM)
• : Any other neurological or psychiatric conditions, including but not limited to autism spectrum disorder (ASD), epilepsy, obsessive-compulsive disorder (OCD), etc
• : Previous head trauma ，Neurological diseases ，Major systemic illnesses

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Tic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Jun Ma, M.D.

CONTACT

13917230745; majun@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)