Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
NCT ID: NCT06742450
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-01-27
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Constant current (CC) subthalamic nucleus deep brain stimulation
Constant current (CC) subthalamic nucleus deep brain stimulation
For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant current (CC) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant current (CC) mode will be maintained.
Constant voltage (CV) subthalamic nucleus deep brain stimulation
Constant voltage (CV) subthalamic nucleus deep brain stimulation
For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant voltage (CV) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant voltage (CV) mode will be maintained.
Interventions
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Constant current (CC) subthalamic nucleus deep brain stimulation
For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant current (CC) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant current (CC) mode will be maintained.
Constant voltage (CV) subthalamic nucleus deep brain stimulation
For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant voltage (CV) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant voltage (CV) mode will be maintained.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 75, no limited sex
* After bilateral STN-DBS, yet not powered on
Exclusion Criteria
* Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy
* Serious health conditions, such as tumors, liver or kidney diseases, etc.
* Epilepsy or other seizure disorders
* Patients with severely deviated electrode placement
* Patients who were unable to voluntarily sign an informed consent form
* Patients who did not agree to cooperate with follow-up
18 Years
75 Years
ALL
No
Sponsors
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Beijing Pins Medical Co., Ltd
INDUSTRY
Chinese PLA General Hospital
OTHER
Tianjin Huanhu Hospital
OTHER
Kunming Sanbo Brain Hospital
UNKNOWN
Xijing Hospital
OTHER
The First People's Hospital of Changde City
OTHER
The General Hospital of Southern Theater Command
OTHER
THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY
UNKNOWN
RenJi Hospital
OTHER
Changshu Hospital of Traditional Chinese Medicine
OTHER
Hainan General Hospital
OTHER
Affiliated Hospital of North Sichuan Medical College
OTHER
Second Affiliated Hospital of Bengbu Medical College
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital of Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Shanshan Mei
Role: primary
Other Identifiers
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PX2024032
Identifier Type: -
Identifier Source: org_study_id