Status:
COMPLETED
PSA Versus STN DBS for TD-PD
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Suzhou Sceneray Medical Co. , Ltd
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 tremor-dominant Pa...
Detailed Description
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targetin...
Eligibility Criteria
Inclusion
- diagnosis of idiopathic Parkinson's disease
- tremor-dominant subtype in the on-medication condition
- modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition
- receiving regular anti-parkinsonian drugs for more than 6 weeks
- good compliance and written informed consent provided
Exclusion
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
- Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05382858
Start Date
June 1 2022
End Date
August 26 2025
Last Update
December 2 2025
Active Locations (1)
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1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025