NCT07147140

Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation

Evaluation of Physiological Parameters in Patients With Complex Regional Pain Syndrome of the Lower Limbs Treated With Dorsal Root Ganglion Stimulation.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: AZ Delta · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

1. Objective and Rationale: The study seeks to evaluate how Dorsal Root Ganglion Stimulation (DRGS) influences autonomic functions in patients suffering from Complex Regional Pain Syndrome type I (CRPS I), offering new metrics beyond pain scores to assess therapeutic efficacy. 2. Innovative Approach: Continuous monitoring of patients using validated, CE-marked biosensors (Corsano Biosensor and Motionwatch8) to collect real-time physiological data during active DRGS therapy and therapy cessation periods. 3. Clinical Impact: Results from this study may improve patient management strategies and refine treatment protocols for individuals living with CRPS I.

Conditions

• CRPS (Complex Regional Pain Syndrome) Type I

Interventions

Type	Name	Description
DEVICE	dorsal root ganglion stimulation cessation	Treatment of DRGS will be stopped at home and physiological parameters will be monitored with bio wearables at home. physiological parameters will be monitored during a baseline period, before stopping DRGS. While DRGS is stopped. And during the period while the DRGS is turned back on.

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Belgium