Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome

Sponsor
Beijing Tiantan Hospital
Study ID
NCT06889480
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • New Target DBS — DEVICE
    Participants in this arm will receive active DBS targeting a novel brain region identified via electrophysiological brain mapping. A DBS electrode will be implanted at the new target, and stimulation parameters (including frequency, voltage, and pulse width) are individually optimized based on mapping and 24-hour testing. The procedure is performed using a robotic system for precise electrode placement, and the device is provided by Beijing PINS Medical Co., Ltd.
  • CM-DBS — DEVICE
    This intervention involves active DBS at the central medial thalamic nucleus (CM) -a widely used target in TS treatment. A DBS electrode is implanted at the CM target, with stimulation settings determined through electrophysiological brain mapping and subsequent 24-hour stimulation. This arm serves as an active comparator, with stimulation administered during a 1-month period in the crossover phase. The same device and robotic-assisted implantation are used to ensure consistency and precision.
  • Sham Stimulation — DEVICE
    Participants assigned to the sham stimulation arm undergo the identical surgical procedure and electrode implantation as those in the active arms. However, during the stimulation periods, the device is programmed to deliver no active stimulation. This sham intervention is designed to control for placebo effects and ensure that any observed improvements in TS symptoms are attributable to the active DBS interventions.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Mar 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Yale Global Tic Severity Scale (YGTSS) Score [ Time Frame: administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulation ]

Central Contacts

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