Actively Recruiting
PSA Versus STN DBS for DT
Led by Ruijin Hospital · Updated on 2024-12-30
20
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
S
Suzhou Sceneray Medical Co. , Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PSA Versus STN DBS for DT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with dystonic tremor based on the MDS 2018 consensus
- Motor symptoms of dystonic tremor present for 3 or more years
- Stable tremor medication doses for at least 28 days prior to consent if applicable
- Good compliance with study procedures and written informed consent provided
You will not qualify if you...
- Intracranial abnormalities preventing DBS surgery
- Significant mental illness affecting study compliance (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
- Severe cognitive impairment with MOCA score below 24
- Current substance or alcohol abuse as defined by DSM-V
- History of recurrent or unprovoked epileptic seizures
- Prior intracranial surgery or device implantation for movement disorders
- History of hemorrhagic stroke
- Significant medical conditions interfering with study or confounding assessments
- Terminal illness with life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
D
Dianyou Li, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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