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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07351955
Enrollment
60
Registered
2026-01-20
Start date
2025-06-01
Completion date
2026-05-31
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tic Disorders

Keywords

Transcranial Magnetic Stimulation

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.

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.

Sponsors

Shanghai Children's Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tic Severity10 weeksThe severity of the child's clinical tic symptoms assessed via the Yale Global Tic Severity Scale.
Changes in brain region activation intensity and resting-state connectivity before and after treatment.10 weeksBased on fMRI imaging, changes in brain region activation intensity (BOLD signals) and resting-state functional connectivity (FC) before and after treatment were compared.

Countries

China

Contacts

CONTACTJun Ma, M.D.
majun@shsmu.edu.cn13917230745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026