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Study Comparing Constant Current and Constant Voltage Deep Brain Stimulation in Parkinsons Disease Patients After Surgery

Led by Xuanwu Hospital, Beijing · Updated on 2024-12-19

180

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two modes of deep brain stimulation DBS for patients with Parkinsons 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

Research Team

S

Shanshan Mei

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