Actively Recruiting
Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)
Led by Xuanwu Hospital, Beijing · Updated on 2025-01-21
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in adults with treatment-resistant Tourette's Syndrome (TR-TS). This neurodevelopmental disorder involves involuntary movements and sounds called tics, which persist despite standard treatments. The study aims to evaluate how SEEG-guided RNS affects symptoms and brain activity in patients with severe and persistent tics who have not responded to behavioral therapy or medications. Participants will have bilateral RNS leads surgically implanted in specific brain targets identified using SEEG brain mapping. The leads connect to a neurostimulator implanted under the skin near the collarbone. The study focuses on various brain regions, and some participants may take part in optional PET scans to see how the stimulation changes brain activity. The therapy and brain mapping help customize stimulation settings for each patient. During the study, participants will be assessed at multiple time points up to 12 months after surgery using various rating scales measuring tic severity, obsessive-compulsive symptoms, anxiety, depression, sleep quality, and overall clinical impression. Cognitive tests will also be performed one year after implantation. Safety will be monitored by recording adverse events throughout the study. The main outcome is the reduction in total tic severity after one year of treatment.
CONDITIONS
Brief Title
Effect of RNS in Treatment-refractory Tourette's Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Able to provide written informed consent
- Diagnosed with Tourette's syndrome according to DSM-IV-TR criteria and confirmed by Mini-International Neuropsychiatric Interview Chinese version 5.0
- Yale Global Tic Severity Scale (YGTSS) score of at least 35 for at least 12 months before surgery, with YGTSS-Total Motor score of 15 or higher
- Failed conventional medical treatment with adequate doses of three classes of medication for at least three months
- Not suitable for behavioral intervention or behavioral intervention was unsuccessful
- Stable comorbid conditions without suicidal ideation for at least six months
You will not qualify if you...
- Presence of other psychotic disorders
- Previous treatment with electroconvulsive therapy (ECT), modified ECT, transcranial direct or alternating current stimulation, deep brain stimulation, or transcranial magnetic stimulation
- Suicide risk defined as 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, lactating, or of childbearing potential who refuse reliable contraception
- Participation in other clinical studies within three months before enrollment
- Any other conditions considered by the study group that may interfere with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo stereotactic surgery where bilateral responsive neurostimulation (RNS) leads are implanted in the brain and connected to a neurostimulator device implanted under the skin near the collarbone.
1 surgical visit and immediate post-operative care
Duration - Up to 12 months post-surgery
Participants receive ongoing personalized responsive neurostimulation therapy targeting specific brain areas to manage treatment-refractory Tourette's Syndrome symptoms.
Visits at week 2, month 1, month 3, month 6, and month 12 for assessments
Duration - Up to 12 months post-surgery
Participants are monitored for long-term effectiveness and safety of the neurostimulation treatment, including optional participation in additional PET brain imaging studies.
Regular follow-up visits aligned with treatment assessment schedule
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Actively Recruiting
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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