Personalized closed-loop non-invasive brain stimulation to treat tics in children
Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in Children
This program will test a personalized, closed-loop transcranial magnetic stimulation (TMS) approach to reduce tics in children and adolescents aged 5 to 18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Months to 18 Years |
| Sex | All |
| Sponsor | Shanghai Children's Medical Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07351955 on ClinicalTrials.gov |
What this trial studies
Researchers will create a personalized, closed-loop non-invasive brain stimulation protocol using TMS guided by each child's brain activity and imaging, combined with behavioral therapy and safety monitoring. Eligible children (5–18 years) who meet DSM-5 criteria for tic disorders, are treatment‑naive, and have FIQ ≥70 will undergo MRI/fMRI and receive individualized stimulation while clinicians record clinical and neurophysiological outcomes. The protocol excludes participants with metal implants, significant head motion during fMRI, non‑right‑handedness, major neurological or psychiatric comorbidities, or FIQ <70. Outcomes will include changes in tic severity, tolerability, and neural-circuit measures to refine precision neuromodulation for pediatric tics.
Who should consider this trial
Good fit: Ideal candidates are treatment‑naive children and adolescents aged 5–18 with DSM-5 tic disorders, normal EEG, FIQ ≥70, right‑handedness, and the ability to undergo MRI/TMS procedures.
Not a fit: Children with FIQ <70, metal implants, non‑right‑handedness, significant comorbid neurological or psychiatric disorders (e.g., ASD, epilepsy, OCD), prior head trauma, or inability to tolerate MRI/TMS are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, this approach could offer a more targeted, non-drug way to reduce tic severity and improve daily functioning in affected children.
How similar studies have performed: Conventional TMS has shown mixed results for tics in older patients, while closed-loop, individualized non-invasive stimulation in pediatric tic disorders is largely novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Children's Medical Center，School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jun Ma, M.D.
- Email: majun@shsmu.edu.cn
- Phone: 13917230745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.