RecruitingNot ApplicableNCT07351955

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

Sponsor

Shanghai Children's Medical Center

Enrollment

60 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Tic Disorders

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.

Eligibility

Min Age: 5 MonthsMax Age: 18 Years

Inclusion Criteria4

: 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)

Exclusion Criteria5

: 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

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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.