Effect of RNS in Treatment-refractory Tourette's Syndrome

Last updated: January 19, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Tic Disorders

Treatment

Responsive Neurostimulation (RNS)

Clinical Study ID

NCT06785532
RNS for TRTS
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ofMental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) criteria and confirmed bythe 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 ofthree classes of medication lasting for at least three months;

  6. must not be suitable for behavioural intervention or that this intervention isinappropriate or unsuccessful;

  7. have been on stable comorbid conditions without suicidal ideation for at least sixmonths.

Exclusion

Exclusion Criteria:

  1. presence of other psychotic disorders;

  2. have a treatment history that includes electroconvulsive therapy (ECT), modifiedelectroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS),transcranial alternating current stimulation (tACS), DBS, and transcranial magneticstimulation (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 useof reliable contraception during the study;

  10. have been involved in other clinical studies within three months before enrollmentin this study;

  11. any conditions considered by the study group.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Responsive Neurostimulation (RNS)
Phase:
Study Start date:
February 05, 2025
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

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