Actively Recruiting
Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome
Led by Beijing Tiantan Hospital · Updated on 2025-05-22
5
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the neural mechanisms underlying Tourette syndrome (TS) and see if personalized deep brain stimulation (DBS) can help reduce tics in TS patients and improve related issues like anxiety, attention problems, and obsessive-compulsive behaviors. In this study, researchers will use stereoelectroencephalography (SEEG) and electrocorticography (ECoG) to record brain activity in key areas involved in movement and emotion, including the nucleus accumbens (NAc), anterior limb of the internal capsule (ALIC), insular cortex, anterior cingulate cortex (ACC), central medial thalamic nucleus (CM), globus pallidus internus (GPi), and motor cortex (M1). They will test stimulation in these areas to evaluate acute therapeutic effect for each target and to identify a new effective new target. Later, participants will receive DBS treatment under three different conditions, each for 1 month to identify the optimal target: 1. Stimulation at the new target, 2. Stimulation at the CM, 3. Sham stimulation (does not actually stimulate). Finally, DBS will be continued at the optimal target for an additional three months to confirm its therapeutic impact. By analyzing the brain activity and comparing these conditions, the study will clarify the neural mechanisms underlying TS and learn which target works best to lower tics and improve overall quality of life for TS patients.
CONDITIONS
Official Title
Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Diagnosis of Tourette Syndrome by DSM-V criteria with multiple motor tics and at least one vocal tic
- Tics present for more than 1 year with onset before age 18
- Yale Global Tic Severity Scale (YGTSS) score greater than 35, motor tic score of at least 15, and tics cause disability
- Inadequate response to standard pharmacological and behavioral treatments
- Disease duration longer than 1 year
- Stable coexisting medical, neurological, or psychiatric disorders for at least 6 months
- Stable psychosocial environment
- Able to tolerate surgery, follow-up, and possible side effects based on neuropsychological evaluation
- Able to provide written informed consent or have a legal representative do so
You will not qualify if you...
- Suicidal risk with score of 3 or higher on suicide items of Hamilton Depression Rating Scale
- Drug or alcohol dependence in the past 6 months
- Abnormal brain structure on CT or MRI scans
- Conditions that could cause surgical failure or interfere with postoperative care
- Diagnosis of factitious disorder, malingering, or psychogenic tics
- Contraindications to neurosurgery such as cerebral infarction or hydrocephalus
- Contraindications to CT or MRI scanning such as claustrophobia
- Pregnancy, lactation, or positive pregnancy test before randomization
- Contraindications to general anesthesia like severe arrhythmia or anemia
- Expected survival less than 12 months
- Participation in other interventional clinical studies affecting outcomes
- Any condition judged by investigators to hinder participation or pose risk
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
H
Hutao Xie, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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