Status:
UNKNOWN
Asymmetric Targeted DBS for PD With PIGD
Lead Sponsor:
Ruijin Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effectiveness of the deep brain stimulation of asymmetric targets \[subthalamic nucleus (STN) in the right hemisphere while globus pallidus interna (GPi) in...
Detailed Description
This is a double-blinded, randomized, controlled trial aiming at comparing the efficacy of asymmetric targets and bilateral STN DBS in treating PD with PIGD. After being informed about the study and ...
Eligibility Criteria
Inclusion
- diagnosis of idiopathic Parkinson's disease
- postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition
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 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 :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05397340
Start Date
September 1 2022
End Date
December 31 2024
Last Update
January 23 2023
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China