Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Tiantan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 60 years.
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.
Disqualifiers
Presence of suicidal risk, defined as a score of ≥3 on the suicide-related items of the Hamilton Depression Rating Scale (HAMD).
History of drug or alcohol dependence within the past 6 months.
Abnormal brain structure as indicated by CT or MRI scans.
Presence of any condition that could lead to surgical failure or interfere with postoperative management.
Trial design
Design model
Crossover
Treatments tested in this trial
New Target DBS
DeviceParticipants 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
DeviceThis 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
DeviceParticipants 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.
Treatment groups
5 Participants
are divided into 3 treatment groupsGroup A: New Target DBSExperimental treatment 1 intervention
Group B: CM-DBSActive comparator 1 intervention
Group C: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Yale Global Tic Severity Scale (YGTSS) Score
The YGTSS is a 10-item semi-structured clinician-rating instrument that evaluates motor and phonic symptoms' number, frequency, intensity, complexity, and interference. The items about the tic ratings are scored on two subscales: motor tics and phonic tics. Behaviors are rated on a 6-point scale. The Total Tic Severity Score ranges from 0-50, with a higher score indicating a higher severity of symptoms.
Time frame
administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulationSecondary outcomes
1
Change in Modified Rush Video Rating Scale (MRVRS)
The Modified Rush Video Rating Scale (MRVRS) is a validated, video-based instrument for objectively assessing tic severity in patients with Tourette Syndrome. The MRVRS evaluates motor and phonic tics using a revised scoring method that captures tic frequency, intensity, and complexity from a 5-minute video recording. The MRVRS ranges from 0-20, with a higher score indicating a higher severity of symptoms. In this study, trained, blinded evaluators will rate each participant's tic severity using the MRVRS at multiple time points. Assessments are performed at baseline, after 1 month of stimulation during each randomized crossover period (following New Target DBS Stimulation, CM DBS Stimulation, and Sham Stimulation), and again after 3 months of continuous optimal stimulation. A decrease in the MRVRS score from baseline will indicate an improvement in tic severity.
Time frame
administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulation2
Change in Premonitory Urge Scale (PUTS) Score
The Premonitory Urge Scale (PUTS) is a self-reported measure that evaluates the intensity of premonitory urges preceding tics in patients with Tourette Syndrome. The PUTS score ranges from 9-36, where higher values reflect more severe urges, will be recorded at baseline, after each 1-month stimulation period during the randomized crossover phase, and after 3 months of continuous optimal stimulation. Changes in the PUTS score will indicate alterations in the severity of premonitory urges.
Time frame
administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulation3
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a clinician-rated instrument that assesses the severity of obsessive-compulsive disorder (OCD). Scores range from 0 (no symptoms) to 40 (severe symptoms). Assessments will be performed at baseline, after each 1-month randomized stimulation phase (following New Target DBS, CM DBS, and Sham stimulation), and after 3 months of continuous optimal stimulation. A reduction in the Y-BOCS score indicates an improvement in OCD symptoms.
Time frame
administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulation4
Change in Conners' Adult ADHD Rating Scale (CAARS) score
The Conners' Adult ADHD Rating Scale (CAARS) will be used to evaluate the severity of attention deficit hyperactivity disorder (ADHD) , including inattention, hyperactivity, and impulsivity. The scale provides a score reflecting overall ADHD severity. Assessments will be conducted at baseline, after each 1-month stimulation period during the randomized crossover phase, and after 3 months of continuous optimal stimulation. A decrease in the CAARS score indicates improvement in ADHD symptoms
Time frame
administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulationOther outcomes
1
New Stimulation Target Identification
This outcome measure assesses the effectiveness of electrophysiological brain mapping (using SEEG) in identifying a novel stimulation target. Success is defined as the reliable identification of a new target based on electrophysiological criteria during brain mapping and subsequent 24-hour stimulation. The proportion of patients with a successfully identified new target will be determined.
Time frame
administered at baseline, 1 month after each randomized stimulation period during the crossover phase, and 3 months after continuous optimal stimulationSponsors and contacts
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Source ClinicalTrials.gov