Effect of RNS in Treatment-refractory Tourette's Syndrome

NCT06785532 | Recruiting

• 1 other identifier: RNS for TRTS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Tourette Syndrome

Keywords

TS, RNS

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 12 months

  The YGTSS is a 10-item semi-structured clinician-rating instrument that evaluates motor and phonic symptoms' number, frequency, intensity, complexity, and interference. The items about the tic ratings are scored on two subscales: motor tics and phonic tics. Behaviors are rated on a 6-point scale. The Total Tic Severity Score ranges from 0-50, with a higher score indicating a higher severity of symptoms.

  Baseline to 12 months post-surgery

Secondary Outcomes (16)

• YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12.

  Baseline to week 2, month 3, month 6, and month 12

• YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12.

  Baseline to week 2, month 3, month 6, and month 12

• YGTSS: remission.

  Baseline to week 2, month 3, month 6, and month 12

• YGTSS: response rate.

  Baseline to week 2, month 3, month 6, and month 12

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12.

  Baseline to week 2, month 3, month 6, and month 12

Study Arms (1)

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

EXPERIMENTAL

Patients will undergo bilateral RNS lead implantation.

Device: Responsive Neurostimulation (RNS)

Interventions

Responsive Neurostimulation (RNS) 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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome; Raine syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+861083198650; wanghongxing@xwh.ccmu.edu.cn

Huang Wang, MD

CONTACT

+861083198650; wanghuang1118@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with Treatment-refractory Tourette's syndrome (TR-TS)

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 21, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

CN (1)