NCT06785532

Effect of RNS in Treatment-refractory Tourette's Syndrome

Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant Tourette's Syndrome (TR-TS).

Detailed description

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.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DEVICE	Responsive Neurostimulation (RNS)	The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Timeline

• Start date: 2025-02-05
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-01-21
• Last updated: 2025-01-21

Locations

1 site across 1 country: China