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OpenTrials
Completed

NCT Number: NCT07147140

Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation

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.

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Key information

Conditions

CRPS (Complex Regional Pain Syndrome) Type I Autonomic Nervous System Diseases Complex Regional Pain Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Delta

Roeselare, 8800, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dorsal root ganglion stimulation cessation

Device

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.

Primary outcomes

  1. Heart Rate

    Time frame: 1 week

    Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

  2. Heart Rate Variability

    Time frame: 1 week

    Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

  3. Respiratory Rate

    Time frame: 1 week

    Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

  4. Blood Pressure

    Time frame: 1 week

    Non-invasive Cuffless Blood Pressure: systolic, mean and diastolic (mmHg), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

  5. Body Temperature

    Time frame: 1 week

    Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

  6. Oxygen Saturation

    Time frame: 1 week

    Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

  7. Sleep Quality

    Time frame: 1 week

    Sleep quality is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked). For each night of sleep, the bed times and get-up times are entered (either manually, graphically or automatically) and the software automatically determines the sleep start and end times. The analysis then utilises the night-time movement data (e.g. immobile mins and mobile mins) to determine the quality of sleep and provides a list of key sleep parameters.

  8. Physical Activity

    Time frame: 1 week

    Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked).

Secondary outcomes

  1. Pain intensity

    Time frame: 1 week

    Pain intensity (patient-reported) will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst possible pain), recorded three times daily.

  2. Sleep quality

    Time frame: 1 week

    Sleep quality (patient-reported) will be evaluated with a five-point Likert scale (1 = strongly disagree to 5 = strongly agree) based on specific sleep-related statements.

  3. Patient Global Impression of Improvement

    Time frame: 1 week

    Patient Global Impression of Improvement (PGI-I) will be used to assess overall patient-perceived change, using a seven-point Likert scale (1 = very much improved, 7 = very much worse).

  4. Pain condition-related medication usage

    Time frame: 1 week

    Medication intake will be recorded daily by the participant as a count of analgesic medication dosages taken.

Sponsors and collaborators

Lead sponsor

AZ Delta

Other

Collaborators

  • Vrije Universiteit Brussel

Registry information

Official study title

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

Acronym: EPIC-DRG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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