NCT06361004

Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome

Investigating the Impact of Deep Brain Stimulation (DBS) in Treatment-refractory Tourette's Syndrome (TR-TS)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) in patients with Treatment-refractory Tourette's syndrome (TR-TS) implantation targeting the Antero-medial globus pallidus interna (GPi), Antero-medial globus pallidus interna (amGPi), Postero-ventrolateral GPi (pvGPi), Centromedian nucleus, substantia periventricularis and nucleus ventro-oralis internus (Cm-Spv-Voi), Centre median nucleus and nucleus ventro-oralis (Cm-Voi), or Nucleus Accumbens/ Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets.

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. Males are more commonly affected than females, and there is a broad spectrum of symptom severity. Treatment-refractory Tourette's Syndrome (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 DBS has the most potential for TR-TS with apparent symptoms. The stimulation targets of DBS for patients with obsessive-compulsive disorder include GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC. However, the DBS case reports are limited and lack high-quality, evidence-based medical evidence. So, this cohort study focuses on the effectiveness of DBS-targeted GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, NA-ALIC, or other unreported nuclei targets on TR-TS. Another goal of this program 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. This separate study is an option and will not affect current study participation. 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 and will not affect current study participation.

Conditions

• Tourette's Syndrome

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation (DBS)	The DBS lead is stereotactically introduced into the target in the brain (GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, NA-ALIC, or other unreported nuclei targets) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Timeline

• Start date: 2024-04-20
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: China