Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
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About
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.
Full description
This is a randomized, parallel controlled, multi-center study 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. Participants will be followed for up to 12 months. Approximately 180 PD participants will be recruited from up to 14 sites. Participants will be randomized to current mode or voltage mode after DBS surgery and be comprehensively assessed at baseline and follow up according to the protocol developed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients with idiopathic Parkinson's disease
- Aged 18 to 75, no limited sex
- After bilateral STN-DBS, yet not powered on
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Shanshan Mei
Data sourced from clinicaltrials.gov
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