BridgeMD
New treatment option for Tourette Syndrome
Official title Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome
ClinicalTrials.gov ID: NCT06889480
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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...
- Inadequate response to conservative treatments (standard pharmacological and behavioral therapy).
- Disease duration of more than 1 year.
You likely can't join if
- 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.
- Diagnosis of factitious disorder, malingering, or psychogenic tics.
- Contraindications to neurosurgical procedures (e.g., history of cerebral infarction, hydrocephalus, cerebral atrophy, or post-stroke sequelae).
See the full eligibility criteria
- 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...
- 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.
- 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.
- Diagnosis of factitious disorder, malingering, or psychogenic tics.
- Contraindications to neurosurgical procedures (e.g., history of cerebral infarction, hydrocephalus, cerebral atrophy, or post-stroke sequelae).
- Contraindications for CT/MRI scanning (e.g., claustrophobia).
- Pregnancy or lactation, or a positive pregnancy test prior to randomization.
- Contraindications to general anesthesia (e.g., severe arrhythmia, severe anemia, hepatic or renal dysfunction).
- Expected survival of less than 12 months.
- Participation in other treatment clinical studies that may influence outcome assessments.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.