MultitArget STereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age between 18 and 60 years.

• 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.

• 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.

• Inadequate response to conservative treatments (standard pharmacological and behavioral therapy).

• Disease duration of more than 1 year.

• Any coexisting medical, neurological, or psychiatric disorders have been treated and remain stable for at least 6 months.

• A stable psychosocial environment.

• Neuropsychological evaluation demonstrating that the candidate can tolerate the surgical procedure, postoperative follow-up, and potential adverse events.

• The participant, or his/her legal representative, is able to provide written informed consent.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Hutao Xie, M.D., Ph.D.
xieht0123@163.com
+8618756921517
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 5
Treatments
Experimental: New Target DBS
Participants in this arm will receive active deep brain stimulation targeted to a novel brain region. The new target is identified through electrophysiological brain mapping and 24-hour stimulation. Stimulation parameters (frequency, voltage, pulse width) will be individually optimized based on mapping results.
Active_comparator: CM-DBS
Participants in this arm will receive active deep brain stimulation at the central medial thalamic nucleus (CM), a well-established target for TS treatment. Stimulation settings are determined during electrophysiological brain mapping and 24-hour stimulation. This arm serves as the active comparator, enabling the evaluation of relative efficacy and safety between the conventional CM target and the new target intervention.
Sham_comparator: Sham Stimulation
Participants in this arm will undergo identical surgical procedures and follow-up assessments as in the active stimulation arms but will receive sham (inactive) stimulation. This arm is designed to control for placebo effects and ensure that any observed improvements in TS symptoms are attributable to the active interventions.
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov