Effect of RNS in Treatment-refractory Tourette's Syndrome

NCT ID: NCT06785532

Last Updated: 2025-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2029-12-31

Brief Summary

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).

Detailed Description

Tourette's 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. There is a broad spectrum of symptom severity. Treatment-refractory TS (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 personalized responsive neurostimulation (RNS) has the most potential for TR-TS with apparent symptoms. However, the RNS case reports are limited and lack high-quality, evidence-based medical evidence. The stimulation targets of RNS for patients with TS include GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC. While stereoelectroencephalography (SEEG) brain mapping can help identify Individualized effective targets and stimulation parameters. So, this cohort study focuses on the effectiveness of SEEG-guided RNS on TR-TS patients. Another goal 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 and different cognitive tasks.

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.

Conditions

Tourette Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment-refractory Tourette's Syndrome (TR-TS)

Patients will undergo bilateral RNS lead implantation.

Group Type: EXPERIMENTAL

Responsive Neurostimulation (RNS)

Intervention Type: DEVICE

The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Interventions

Responsive Neurostimulation (RNS)

The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Wang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+861083198650

Huang Wang, MD

Role: CONTACT

wanghuang1118@163.com

+861083198650

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

wanghongxing@xwh.ccmu.edu.cn

+861083198650

Other Identifiers

RNS for TRTS

Identifier Type: -

Identifier Source: org_study_id