Study of Personalized Responsive Neurostimulation Therapy Guided by Brain Mapping for Adults with Treatment-Resistant Tourettes Syndrome

What this Trial Is About

Researchers are investigating the effect of personalized responsive neurostimulation RNS therapy guided by stereoelectroencephalography SEEG in adults with treatment-resistant Tourettes Syndrome TR-TS. This neurodevelopmental disorder involves involuntary movements and sounds called tics, which persist despite standard treatments. The study aims to evaluate how SEEG-guided RNS affects symptoms and brain activity in patients with severe and persistent tics who have not responded to behavioral therapy or medications. Participants will have bilateral RNS leads surgically implanted in specific brain targets identified using SEEG brain mapping. The leads connect to a neurostimulator implanted under the skin near the collarbone. The study focuses on various brain regions, and some participants may take part in optional PET scans to see how the stimulation changes brain activity. The therapy and brain mapping help customize stimulation settings for each patient. During the study, participants will be assessed at multiple time points up to 12 months after surgery using various rating scales measuring tic severity, obsessive-compulsive symptoms, anxiety, depression, sleep quality, and overall clinical impression. Cognitive tests will also be performed one year after implantation. Safety will be monitored by recording adverse events throughout the study. The main outcome is the reduction in total tic severity after one year of treatment.

Effect of RNS in Treatment-refractory Tourette's Syndrome