Effect of RNS in Treatment-refractory Tourette's Syndrome

Tourette's Syndrome (TS) is a neurodevelopmental disorder characterized by repetitive, involuntary movements and vocalizations known as tics. It typically manifests in childhood and may persist into adulthood. The prevalence of TS varies globally, affecting approximately 1% of the population. There is a broad spectrum of symptom severity. Treatment-refractory TS (TR-TS) refers to cases where standard therapeutic interventions, such as behavioural therapy and medications, have shown limited effectiveness. TR-TS prevalence is relatively lower but highlights the challenges in managing severe and persistent symptoms. In a comprehensive survey of diverse neuromodulation therapies, targeting specific nuclei with personalized responsive neurostimulation (RNS) has the most potential for TR-TS with apparent symptoms. However, the RNS case reports are limited and lack high-quality, evidence-based medical evidence. The stimulation targets of RNS for patients with TS include GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC. While stereoelectroencephalography (SEEG) brain mapping can help identify Individualized effective targets and stimulation parameters. So, this cohort study focuses on the effectiveness of SEEG-guided RNS on TR-TS patients. Another goal is to study the neuronal activity of the GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC, or other unreported nuclei targets, respectively. At the same time, some subjects are presented with a task involving an unexpected reward and different cognitive tasks.

Some participants will also be invited to join a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional.

• YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• YGTSS: remission. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• YGTSS: response rate. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S) Remove [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L. [Time frame: Baseline to week 2, month 3, month 6, and month 12]
• Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. [Time frame: Baseline to week 2, month 3, month 6, and month 12]