Actively Recruiting
Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in Children
Led by Shanghai Children's Medical Center · Updated on 2026-01-20
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new personalized treatment approach using non-invasive brain stimulation combined with behavioral therapy for children and adolescents aged 5 to 18 years who have Tic Disorders. The study aims to understand how this treatment affects brain circuits, improve the effectiveness of transcranial magnetic stimulation (TMS), and develop precise brain modulation methods tailored for pediatric patients with Tic Disorders. Participants will be randomly assigned to one of two groups. In the intervention group, children will receive TMS using a ZL-N-010 device targeted at specific brain areas including the prefrontal, bilateral temporal, and parietal lobes, with each session lasting about 30 minutes over 10 sessions. They will also receive general behavioral therapy aimed at managing symptoms. The control group will receive sham (placebo) stimulation along with the same behavioral therapy. Throughout the 10-week study period, participants will have their tic severity and brain activity assessed before and after treatment. Brain scans will measure changes in activation and connectivity in targeted regions. Researchers will monitor the treatment effects and safety, with the total study duration including these assessments. The study is sponsored by Shanghai Children's Medical Center and begins in June 2025.
CONDITIONS
Brief Title
Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 5 to 18 years
- Diagnosis of Tic Disorders according to DSM-5 criteria with normal EEG
- No prior treatment for Tic Disorders
- Full-scale intelligence quotient (FIQ) of 70 or higher on the Wechsler Intelligence Scale for Children-Revised (WISC-R)
You will not qualify if you...
- Full-scale intelligence quotient (FIQ) below 70 on WISC-R
- Presence of metal implants in the body or non-right-handedness
- Head movement greater than 2mm during fMRI scanning
- Any other neurological or psychiatric conditions including autism spectrum disorder, epilepsy, or obsessive-compulsive disorder
- History of head trauma, neurological diseases, or major systemic illnesses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 weeks
Participants receive transcranial magnetic stimulation sessions targeting specific brain areas and general behavioral therapy. Each TMS session lasts about 30 minutes, with a total of 10 sessions.
10 visits (in-person), each lasting about 30 minutes
Duration - Up to 5 weeks after treatment
Participants are monitored after treatment to assess changes in tic severity and brain activity.
Visits as scheduled to assess outcomes up to 10 weeks total
Trial Site Locations
Total: 1 location
1
Shanghai Children's Medical Center，School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
J
Jun Ma, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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