Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome

NCT06361004 | Not Yet Recruiting

• 1 other identifier: DBS for TR-TS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tourette's Syndrome

Keywords

TS, DBS

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 6 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 6 months post-surgery

Secondary Outcomes (15)

• 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, and 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

• Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score.

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

Study Arms (1)

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

EXPERIMENTAL

Patients will undergo bilateral DBS lead implantation.

Device: Deep Brain Stimulation (DBS)

Interventions

Deep Brain Stimulation (DBS) DEVICE

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.

Patients with 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

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Deep Brain Stimulation

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolei Liu, MD & PhD

CONTACT

+86 10 83198650; ring@vip.163.com

Wenfeng Zhao, MD

CONTACT

+86 10 83198650; fengfeng_zw@ccmu.edu.cn

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: April 8, 2024
• First Posted: April 11, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 11, 2024

Record last verified: 2024-01

Locations

CN (1)