NCT06012461

Closed-loop DBS in Parkinson's Disease

Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tsinghua University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Closed-loop DBS stimulation for 24 hours	Continuous closed-loop modulation for 24 hours
OTHER	Open-loop DBS stimulation for 24 hours	Continuous open-loop modulation for 24 hours
OTHER	Closed-loop DBS stimulation for 72 hours	Continuous closed-loop modulation for 72 hours
OTHER	Open-loop DBS stimulation for 72 hours	Continuous open-loop modulation for 72 hours

Timeline

• Start date: 2023-06-30
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2023-08-25
• Last updated: 2023-09-05

Locations

1 site across 1 country: China