Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Magnetic Stimulation, general behavioral therapy.
- Who it may be relevant to
- Registry conditions: Tic Disorders. Basic parameters: 5 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Transcranial 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. - Behavioral general 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.
Primary outcome measures
- Tic Severity [Time frame: 10 weeks]
- Changes in brain region activation intensity and resting-state connectivity before and after treatment. [Time frame: 10 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Children's Medical Center，School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT07351955 · LY202504140