Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
1 other identifier
interventional
180
1 country
1
Brief Summary
To compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2024
CompletedFirst Submitted
Initial submission to the registry
December 16, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedDecember 19, 2024
December 1, 2024
2.2 years
December 16, 2024
December 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The change rate of MDS-UPDRS III
MDS-UPDRS III is the motor examination section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), completed by the evaluator, providing an objective assessment of motor symptoms in patients with Parkinson's disease. MDS-UPDRS III ranges from 0-132. The change rate of MDS-UPDRS III in the Stim-On/Med-On state from baseline to 6 months after surgery will be collected. Positive indicates improvement.
from baseline to 6 months after surgery
Secondary Outcomes (9)
MDS-UPDRS I
from baseline to 6 months after surgery
MDS-UPDRS II
from baseline to 6 months after surgery
MDS-UPDRS IV
from baseline to 6 months after surgery
Clinical Global Impression (CGI)
from baseline to 6 months after surgery
Physician satisfaction feedback
from baseline to 6 months after surgery
- +4 more secondary outcomes
Study Arms (2)
Constant current (CC) subthalamic nucleus deep brain stimulation
EXPERIMENTALConstant voltage (CV) subthalamic nucleus deep brain stimulation
ACTIVE COMPARATORInterventions
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.
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
You may qualify if:
- Patients with idiopathic Parkinson's disease
- Aged 18 to 75, no limited sex
- After bilateral STN-DBS, yet not powered on
You may not qualify if:
- Mental disorders or dementia
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuanwu Hospital, Beijinglead
- Beijing Pins Medical Co., Ltdcollaborator
- Chinese PLA General Hospitalcollaborator
- Tianjin Huanhu Hospitalcollaborator
- Kunming Sanbo Brain Hospitalcollaborator
- Xijing Hospitalcollaborator
- The First People's Hospital of Changde Citycollaborator
- The General Hospital of Southern Theater Commandcollaborator
- THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITYcollaborator
- RenJi Hospitalcollaborator
- Changshu Hospital of Traditional Chinese Medicinecollaborator
- Hainan General Hospitalcollaborator
- Affiliated Hospital of North Sichuan Medical Collegecollaborator
- Second Affiliated Hospital of Bengbu Medical Collegecollaborator
Study Sites (1)
Xuanwu Hospital of Capital Medical University
Beijing, 100053, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2024
First Posted
December 19, 2024
Study Start
January 27, 2024
Primary Completion
March 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
December 19, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share