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Clinical Trials in China / NCT06361004
Starting soon Not applicable

Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome

NCT06361004 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-04-20
Last updated
2024-04-11

Condition(s) studied

Tourette's Syndrome

Investigational drug(s) / intervention(s)

Deep Brain Stimulation (DBS)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. aged 18-65; 2. able to provide written informed consent; 3. 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; 4. with a YGTSS of at least 35 for at least 12 months before surgery, while YGTSS- Total Motor≥15; 5. must have failed conventional medical treatment at adequate therapeutic doses of three classes of medication lasting for at least three months; 6. must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful; 7. have been on stable comorbid conditions without suicidal ideation for at least six months. Exclusion Criteria: 1. presence of other psychotic disorders; 2. 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); 3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items); 4. experience difficulty in effectively communicating with investigators; 5. with a history of traumatic brain injury (TBI); 6. with intracranial or cardiovascular stents; 7. substance abuse within the past six months; 8. unstable neurological or coagulation disorders; 9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study; 10. have been involved in other clinical studies within three months before enrollment in this study; 11. any conditions considered by the study group.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China

More Xuanwu Hospital, Beijing trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06361004 on ClinicalTrials.gov ↗ ← All trials in China