Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation (EPIC-DRG)

AZ Delta

Status

Active, not recruiting

Conditions

CRPS (Complex Regional Pain Syndrome) Type I

Treatments

Device: dorsal root ganglion stimulation cessation

Study type

Interventional

Funder types

Other

Identifiers

ANE 20241129

Details and patient eligibility

About

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.
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.
Clinical Impact: Results from this study may improve patient management strategies and refine treatment protocols for individuals living with CRPS I.

Enrollment

36 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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