Study of Personalized Non-Invasive Brain Stimulation for Treating Tic Disorders in Children and Teens

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 Childrens Medical Center and begins in June 2025.

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