Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06361004, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT06361004
- Record updated
- 11 April 2024
- Original description
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.Read full original descriptionShow less
Investigating the Impact of Deep Brain Stimulation (DBS) in Treatment-refractory Tourette's Syndrome (TR-TS)
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.
Inclusion: aged 18-65; able to provide written informed consent; have a diagnosis of Tourette's syndrome according to the Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) criteria and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0; with a YGTSS of at least 35 for at least 12 months before surgery, while YGTSS- Total Motor≥15; must have failed conventional medical treatment at adequate therapeutic doses of three classes of medication lasting for at least three months; must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful; have been on stable comorbid conditions without suicidal ideation for at least six months.
Exclusion: have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS); have been involved in other clinical studies within three months before enrollment in this study; presence of other psychotic disorders; with a history of traumatic brain injury (TBI); unstable neurological or coagulation disorders; any conditions considered by the study group; presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items); experience difficulty in effectively communicating with investigators; with intracranial or cardiovascular stents; substance abuse within the past six months; women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study.