Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06361004
Study type	Interventional
Source	Xuanwu Hospital, Beijing
Contact	Xiaolei Liu, MD & PhD
Phone	+86 10 83198650
Email	ring@vip.163.com
Status	Not yet recruiting
Phase	N/A
Start date	April 20, 2024
Completion date	December 31, 2029

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.