CompletedNot Applicable

Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation

Belgium24 participantsStarted 2025-09-08

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Rate

Timeframe: 1 week

Heart Rate Variability

Timeframe: 1 week

Respiratory Rate

Timeframe: 1 week

Blood Pressure

Timeframe: 1 week

Body Temperature

Timeframe: 1 week

Oxygen Saturation

Timeframe: 1 week

Sleep Quality

Timeframe: 1 week

Physical Activity

Timeframe: 1 week

Trial details

NCT IDNCT07147140

SponsorAZ Delta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-24

View on ClinicalTrials.gov More CRPS (Complex Regional Pain Syndrome) Type I trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.