Personalized deep brain stimulation for Tourette syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to explore the neural mechanisms of Tourette syndrome (TS) and assess the effectiveness of personalized deep brain stimulation (DBS) in reducing tics and improving associated issues such as anxiety and attention problems. Researchers will utilize advanced techniques like stereoelectroencephalography (SEEG) and electrocorticography (ECoG) to record brain activity in critical areas related to movement and emotion. Participants will undergo DBS treatment under three different conditions over one-month periods to identify the most effective stimulation target for their symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 60 years.
2. Diagnosis of Tourette Syndrome according to DSM-V criteria, defined as:

   i. The presence of multiple motor tics and at least one vocal tic at some point (not necessarily simultaneous).

   ii. Tics that have persisted for more than 1 year from their onset.

   iii. Onset of tics occurring before the age of 18.

   iv. The disorder is not attributable to the physiological effects of a substance or another medical condition.
3. A Yale Global Tic Severity Scale (YGTSS) total score greater than 35 (on a scale of 0-50) for at least 1 year, with a motor tic score of ≥15, and tics being the primary cause of disability.
4. Inadequate response to conservative treatments (standard pharmacological and behavioral therapy).
5. Disease duration of more than 1 year.
6. Any coexisting medical, neurological, or psychiatric disorders have been treated and remain stable for at least 6 months.
7. A stable psychosocial environment.
8. Neuropsychological evaluation demonstrating that the candidate can tolerate the surgical procedure, postoperative follow-up, and potential adverse events.
9. The participant, or his/her legal representative, is able to provide written informed consent.

Exclusion Criteria:

1. Presence of suicidal risk, defined as a score of ≥3 on the suicide-related items of the Hamilton Depression Rating Scale (HAMD).
2. History of drug or alcohol dependence within the past 6 months.
3. Abnormal brain structure as indicated by CT or MRI scans.
4. Presence of any condition that could lead to surgical failure or interfere with postoperative management.
5. Diagnosis of factitious disorder, malingering, or psychogenic tics.
6. Contraindications to neurosurgical procedures (e.g., history of cerebral infarction, hydrocephalus, cerebral atrophy, or post-stroke sequelae).
7. Contraindications for CT/MRI scanning (e.g., claustrophobia).
8. Pregnancy or lactation, or a positive pregnancy test prior to randomization.
9. Contraindications to general anesthesia (e.g., severe arrhythmia, severe anemia, hepatic or renal dysfunction).
10. Expected survival of less than 12 months.
11. Participation in other interventional clinical studies that may influence outcome assessments.
12. Any other condition that, in the investigator's judgment, renders the candidate unsuitable for participation or poses a significant risk (e.g., inability to understand study procedures or poor adherence).

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jianguo Zhang, M.D., Ph.D. — Beijing Tiantan Hospital
• Study coordinator: Hutao Xie, M.D., Ph.D.
• Email: xieht0123@163.com
• Phone: +8618756921517

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for pediatric deep brain stimulation outcomes

  This study is creating a database to collect information on how deep brain stimulation helps children with movement disorders like dystonia and Tourette syndrome, to see how safe and effective the treatment is.

  Recruiting Boston Children's Hospital · Boston, Massachusetts · NCT06585618

• How physical activity might help people with Parkinson’s disease who have DBS-STN implants

  This study tests whether adding regular physical activity can help people with Parkinson’s who have DBS-STN stimulation by trying a structured physiotherapy approach alongside standard care.

  Recruiting Medical University of Warsaw · Warsaw · NCT07838636

• See if deep brain stimulation for Parkinson's changes thinking and movement and affects fall risk

  This pilot study tests whether deep brain stimulation in people with Parkinson’s changes thinking or movement and whether those changes relate to how often they fall.

  Recruiting University of Alabama at Birmingham · Homewood, Alabama · NCT07725315

• How aerobic exercise (forced vs voluntary cycling) affects movement, thinking, and brain signals in people with Parkinson’s and deep brain stimulation

  This study tests whether forced or voluntary cycling improves movement, thinking, and brain activity in people with Parkinson’s who already have a DBS device.

  Recruiting Phase 2 The Cleveland Clinic · Cleveland, Ohio · NCT07442747

• Low-intensity focused ultrasound for movement and seizure disorders

  This trial will try low-intensity focused ultrasound (LIFUS) to see if it can safely change brain activity in people with movement disorders or epilepsy.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07417280

• Patterned deep brain stimulation delivered at home for Parkinson's

  This study will test whether three types of patterned deep brain stimulation can be used safely and comfortably at home in people with Parkinson's who already have stable bilateral STN or GPi Boston Scientific DBS systems.

  Recruiting University of Florida · Gainesville, Florida · NCT07410598

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.