Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06785532

Investigating Responsive Neurostimulation (RNS) Therapy for Adults with Treatment-resistant Tourette's Syndrome Using Stereoelectroencephalography (SEEG) to Guide Personalized Brain Stimulation

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

Researchers are evaluating the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in adults with treatment-resistant Tourette's Syndrome (TR-TS). Tourette's Syndrome is a neurodevelopmental disorder causing repetitive, involuntary movements and vocalizations called tics, often starting in childhood and sometimes persisting into adulthood. This study focuses on patients whose symptoms have not improved with standard treatments like behavioral therapy and medications and aims to understand how SEEG-guided RNS can help manage these severe symptoms. It also explores neuronal activity in several brain targets including GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, and NA-ALIC, and optionally involves cognitive tasks and unexpected reward tests. The study involves implanting an RNS device where a lead is stereotactically placed into specific brain targets and connected to a neurostimulator implanted under the skin near the collarbone. This device delivers responsive stimulation tailored to the individual's brain activity to address their tics. Some participants may also take part in an optional related study using positron emission tomography (PET) scans to observe how brain activity changes in response to the stimulation. Participants will be involved in assessments over 12 months, including evaluation of tic severity using the Yale Global Tic Severity Scale (YGTSS) to measure changes from baseline to one year after surgery. Researchers will monitor neuronal activity, cognitive responses, and safety throughout the study. The total duration includes the implantation procedure, follow-up visits, and ongoing monitoring, with optional PET scanning for additional brain activity data.

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

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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

H

Huang Wang, MD

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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