Personalized deep brain stimulation for Tourette syndrome

MultitArget STereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome

This study is testing if personalized deep brain stimulation can help people with Tourette syndrome reduce their tics and improve related issues like anxiety and attention problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06889480 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of Tourette syndrome who have not responded adequately to standard treatments.

Not a fit: Patients with tics attributable to other medical conditions or those who have not had stable treatment for coexisting disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce tics and improve quality of life for patients with Tourette syndrome.

How similar studies have performed: While there have been studies on deep brain stimulation for movement disorders, this specific approach targeting Tourette syndrome is relatively novel.

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).

Where this trial is running

Beijing, Beijing Municipality

• 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.

Conditions Tourette Syndrome; Deep Brain Stimulation; Tourette syndrome; Electrophysiology; Tics; Psychiatric Comorbidities; Biomarker