Multitarget Recording and Stimulation for Tourette Syndrome

Launched by BEIJING TIANTAN HOSPITAL · Mar 16, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how the brain works in people with Tourette syndrome (TS) and exploring a treatment option called deep brain stimulation (DBS) to help reduce tics and improve related issues like anxiety and attention problems. Researchers will be recording brain activity in important areas and testing different stimulation methods to find the most effective way to help patients. Participants will undergo DBS treatment under three different conditions over several months to determine which one works best.

To be eligible for this trial, participants should be between the ages of 18 and 60, have a diagnosis of Tourette syndrome with persistent tics for over a year, and have not responded well to standard treatments. They should also be in a stable environment and able to give consent. Throughout the trial, participants can expect to receive careful monitoring and support as researchers work to identify the best approach to improve their quality of life. This study is currently recruiting, and it aims to provide new insights into TS and potentially lead to better treatment options.

Gender

ALL

Eligibility criteria

• 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).