PSA Versus STN DBS for DT

Recruiting now · Not applicable

Conditions studied: Dystonic Tremor

In brief

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.

Key facts

Study ID

NCT06752434

Run by

Ruijin Hospital

People needed

20

Starts

2024-12-01

Expected to finish

2029-03-01

Last updated by the study team

2024-12-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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