Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06785532

Effect of RNS in Treatment-refractory Tourette's Syndrome

Led by Xuanwu Hospital, Beijing · Updated on 2025-01-21

10

Participants Needed

1

Research Sites

255 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of RNS in Treatment-refractory Tourette's Syndrome

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 65 years
  • Able to provide written informed consent
  • Diagnosed with Tourette's syndrome according to DSM-IV-TR criteria and confirmed by a standardized interview
  • Yale Global Tic Severity Scale (YGTSS) score of at least 35 for at least 12 months before surgery, with a total motor tic score of 15 or higher
  • Have failed conventional medical treatment with adequate doses of three medication classes for at least three months
  • Not suitable for behavioral intervention or have had unsuccessful behavioral interventions
  • Stable comorbid conditions without suicidal thoughts for at least six months
Not Eligible

You will not qualify if you...

  • Presence of psychotic disorders
  • History of treatments including electroconvulsive therapy, transcranial stimulation, deep brain stimulation, or similar neuromodulation therapies
  • Suicide risk indicated by a score of 3 or higher on suicide-related items of HAMD-17
  • Difficulty communicating effectively with investigators
  • History of traumatic brain injury
  • Presence of intracranial or cardiovascular stents
  • Substance abuse within the past six months
  • Unstable neurological or coagulation disorders
  • Women who are pregnant, breastfeeding, or of childbearing potential refusing reliable contraception during the study
  • Participation in other clinical studies within three months before enrollment
  • Any other conditions considered unsuitable by the study team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xuanwu Hospital, Capital Medical University

Beijing, China, 100053

Actively Recruiting

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Research Team

H

Hongxing Wang, MD & PhD

CONTACT

H

Huang Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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