Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation

NCT07147140 | Completed DMC

• 1 other identifier: ANE 20241129
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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

Keywords

Complex regional pain syndrome type 1; dorsal root ganglion stimulation; automonic outcome parameters

Outcome Measures

Primary Outcomes (8)

• Heart Rate

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

  1 week

• Heart Rate Variability

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

  1 week

• Respiratory Rate

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

  1 week

• Blood Pressure

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

  1 week

• Body Temperature

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

  1 week

• Oxygen Saturation

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

  1 week

• Sleep Quality

  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.

  1 week

• Physical Activity

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

  1 week

Secondary Outcomes (4)

• Pain intensity

  1 week

• Sleep quality

  1 week

• Patient Global Impression of Improvement

  1 week

• Pain condition-related medication usage

  1 week

Study Arms (1)

Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I.

EXPERIMENTAL

Device: dorsal root ganglion stimulation cessation

Interventions

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.

Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Delta: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

AZ Delta

Roeselare, 8800, Belgium

Location

Related Publications (1)

• Patterson DG, Wilson D, Fishman MA, Moore G, Skaribas I, Heros R, Dehghan S, Ross E, Kyani A. Objective wearable measures correlate with self-reported chronic pain levels in people with spinal cord stimulation systems. NPJ Digit Med. 2023 Aug 15;6(1):146. doi: 10.1038/s41746-023-00892-x.

  PMID: 37582839 RESULT

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: August 28, 2025
• Study Start: September 8, 2025
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Anticipated start date 29th April 2025 and anticipated end date 31st of October 2025.
• Access Criteria: Vrije Universiteit Brussel (Research Stimulus Group). They will access the data through an API provided by AZ Delta Research Center.

Locations

BE (1)