Personalized neurostimulation for Tourette's Syndrome

Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)

This study is testing a personalized brain stimulation treatment for adults with Tourette's Syndrome who haven't found relief from other therapies to see if it can help reduce their severe tics.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06785532 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of personalized responsive neurostimulation (RNS) therapy in patients with treatment-resistant Tourette's Syndrome (TR-TS). It utilizes stereoelectroencephalography (SEEG) to identify individualized stimulation targets in the brain, aiming to alleviate severe tics that have not responded to conventional treatments. The study focuses on patients aged 18-65 who have experienced significant symptoms for at least 12 months and have failed multiple medication classes. By mapping neuronal activity in specific brain regions, the study seeks to provide a tailored approach to managing TR-TS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of Tourette's Syndrome who have not responded to standard treatments.

Not a fit: Patients with other psychotic disorders or those who have undergone certain neuromodulation therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the severity of tics in patients with treatment-resistant Tourette's Syndrome.

How similar studies have performed: While there is limited high-quality evidence for RNS in Tourette's Syndrome, similar neuromodulation approaches have shown promise in other conditions.

Eligibility criteria

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.

Where this trial is running

Beijing

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

Study contacts

• Principal investigator: Hongxing Wang, MD & PhD — Xuanwu Hospital, Beijing
• Study coordinator: Hongxing Wang, MD & PhD

Conditions Tourette Syndrome; TS, RNS