Status:
ACTIVE_NOT_RECRUITING
Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation
Lead Sponsor:
AZ Delta
Collaborating Sponsors:
Vrije Universiteit Brussel
Conditions:
CRPS (Complex Regional Pain Syndrome) Type I
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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 (CRP...
Eligibility Criteria
Inclusion
- Patients diagnosed with Complex Regional Pain Syndrome Type I (CRPS I) of the lower limbs.
- Currently treated with Dorsal Root Ganglion Stimulation (DRGS).
- Patients must experience \> 50% pain relief with DRGS therapy for at least three months.
- Willingness and ability to comply with the study requirements, including wearing biosensors, and sharing their physiological parameters.
Exclusion
- Refusal or inability to wear biosensor wearables.
- Current pregnancy.
- Patients with other significant medical conditions that could affect autonomic function.
- Known allergies or intolerance to materials used in biosensors.
- Diagnosis of untreated Obstructive Sleep Apnea Syndrome (OSAS).
- Ongoing psychiatric disorders
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07147140
Start Date
April 15 2025
End Date
November 30 2025
Last Update
August 28 2025
Active Locations (1)
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1
AZ Delta
Roeselare, Belgium, 8800