Actively Recruiting
Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
Led by Xuanwu Hospital, Beijing · Updated on 2024-12-19
180
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
B
Beijing Pins Medical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two modes of deep brain stimulation (DBS) for patients with Parkinson's Disease (PD). This study aims to compare the effectiveness, programming complexity, power use, and satisfaction of both physicians and patients between constant current and constant voltage modes of DBS one year after surgery. The trial is randomized, controlled, and conducted across multiple centers with about 180 participants. Participants will undergo bilateral subthalamic nucleus DBS surgery and then be randomly assigned to either the constant current or constant voltage mode one week after surgery. Each participant will continue with their assigned mode for the full year of follow-up. The study will monitor changes in motor symptoms, satisfaction levels, device power consumption, and other clinical measures throughout the 12 months. During the study, participants will be comprehensively assessed at the start and at regular intervals up to 12 months after surgery. Evaluations include motor symptom scores using the MDS-UPDRS, clinical impressions, satisfaction feedback from both physicians and patients, and monitoring of adverse effects. Power consumption and device impedance will also be measured to understand technical performance. This thorough follow-up provides detailed information on the impact of each stimulation mode over time.
CONDITIONS
Brief Title
Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with idiopathic Parkinson's disease
- Aged 18 to 75, any gender
- Have undergone bilateral subthalamic nucleus DBS surgery but device not yet powered on
You will not qualify if you...
- Mental disorders or dementia
- Pregnant, lactating women, or women unable to prevent pregnancy
- Serious health conditions such as tumors, liver or kidney diseases
- Epilepsy or other seizure disorders
- Severely deviated electrode placement
- Unable to voluntarily sign informed consent
- Unwilling to cooperate with follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo bilateral subthalamic nucleus deep brain stimulation (DBS) surgery before the device is powered on.
Surgery visit and immediate post-operative visits
Duration - 12 months
Participants receive either constant current or constant voltage DBS mode starting one week after surgery, maintained for one year with possible programming adjustments.
Baseline visit and follow-up visits over 12 months
Duration - Up to 12 months
Participants are assessed for adverse effects and treatment outcomes up to 12 months after surgery.
Regular follow-up visits during the treatment period
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital of Capital Medical University
Beijing, China, 100053
Actively Recruiting
Research Team
S
Shanshan Mei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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