RecruitingNot ApplicableNCT06752434
PSA Versus STN DBS for DT
Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: a Prospective, Randomized, Double-blinded, Cross-over Trial
Sponsor
Ruijin Hospital
Enrollment
20 participants
Start Date
Dec 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria4
- Diagnosed with dystonic tremor based on the MDS 2018 consensus
- Duration of DT symptoms: ≥3 years of motor symptoms
- If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
- Good compliance and written informed consent
Exclusion Criteria6
- Any intracranial abnormalities that would prevent DBS surgery
- Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
- Severe cognitive impairment, MOCA score <24
- Any current substance or alcohol abuse according to DSM-V criteria
- Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
- Any terminal illness with a life expectancy of <1 year
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Interventions
DEVICEDeep brain stimulation
active DBS with optimal stimulating parameters
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06752434