Effect of RNS in Treatment-refractory Tourette's Syndrome

Recruiting now · Not applicable

Conditions studied: Tourette Syndrome

In brief

The study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant Tourette's Syndrome (TR-TS).

Key facts

Study ID

NCT06785532

Run by

Xuanwu Hospital, Beijing

People needed

10

Starts

2025-02-05

Expected to finish

2029-12-31

Last updated by the study team

2025-01-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• presence of other psychotic disorders;
• 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);
• presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
• experience difficulty in effectively communicating with investigators;
• with a history of traumatic brain injury (TBI);
• with intracranial or cardiovascular stents;
• substance abuse within the past six months;
• unstable neurological or coagulation disorders;
• women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
• have been involved in other clinical studies within three months before enrollment in this study;
• any conditions considered by the study group.

Where it is running

• Xuanwu Hospital, Capital Medical University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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