Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-08
Brief Title:
Exploring DBS Efficacy in Treatment-refractory Tourettes Syndrome
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Investigating the Impact of Deep Brain Stimulation DBS in Treatment-refractory Tourettes Syndrome TR-TS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to investigate the effect of deep brain stimulation DBS in patients with Treatment-refractory Tourettes 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:
Tourettes 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 Tourettes 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None