CRPS (Complex Regional Pain Syndrome) Type IEPIC-DRGNCT07147140
Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation
A study testing dorsal root ganglion stimulation cessation in people with CRPS (Complex Regional Pain Syndrome) Type I, run by AZ Delta at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- CRPS (Complex Regional Pain Syndrome) Type I
- What is being tested?
- dorsal root ganglion stimulation cessation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Sep 2025to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Physiological Parameters in Patients With Complex Regional Pain Syndrome of the Lower Limbs Treated With Dorsal Root Ganglion Stimulation.
- 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.
- Being tested
- dorsal root ganglion stimulation cessation
- Keywords
- Complex regional pain syndrome type 1, dorsal root ganglion stimulation, automonic outcome parameters
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dorsal root ganglion stimulation cessationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I. | Experimental | Not described Receives: Device: dorsal root ganglion stimulation cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Measured: 1 week
Heart Rate Variability
Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Measured: 1 week
Respiratory Rate
Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Measured: 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)
Measured: 1 week
Body Temperature
Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Measured: 1 week
Oxygen Saturation
Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Measured: 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.
Measured: 1 week
Physical Activity
Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked).
Measured: 1 week
Secondary outcomes (4)
Pain intensity
Pain intensity (patient-reported) will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst possible pain), recorded three times daily.
Measured: 1 week
Sleep quality
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.
Measured: 1 week
Patient Global Impression of Improvement
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).
Measured: 1 week
Pain condition-related medication usage
Medication intake will be recorded daily by the participant as a count of analgesic medication dosages taken.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start8 Sep 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CRPS (Complex Regional Pain Syndrome) Type IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Delta
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147140
- Sponsor's protocol ID
- ANE 20241129
- Acronym
- EPIC-DRG
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description: De-identified individual participant data (IPD), including physiological parameters (heart rate variability, respiratory rate, blood pressure, oxygen saturation, skin temperature) and secondary outcomes (pain intensity scores, sleep quality assessments, medication intake, and patient global impression of improvement) will be shared with the Research Stimulus Group at Vrije Universiteit Brussel. The data will be used for real-time monitoring, statistical analysis, and preparation of scientific manuscripts related to this study. Access Criteria: Access to the IPD will be restricted to members of the Research Stimulus Group who are directly involved in the analysis and interpretation of the EPIC-DRG study data. Data handling will fully comply with GDPR regulations and institutional data protection policies. No public sharing of raw data is planned. Time Frame: Data will be transmitted continuously throughout the study period to enable interim analysis and monitoring, w
Publications
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.
PubMed 37582839
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physiological Parameters in Patients With Complex Regional Pain Syndrome of the Lower Limbs Treated With Dorsal Root Ganglion Stimulation.
- ClinicalTrials.gov ID
- NCT07147140
- Acronym / sponsor ID
- EPIC-DRG / ANE 20241129
- Keywords
- Complex regional pain syndrome type 1, dorsal root ganglion stimulation, automonic outcome parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AZ DeltaUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I. | Experimental | Device: dorsal root ganglion stimulation cessation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dorsal root ganglion stimulation cessationTreatment 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. | Device | Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I. |
Primary outcome
Heart Rate
Time frame: 1 week
Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Heart Rate Variability
Time frame: 1 week
Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Respiratory Rate
Time frame: 1 week
Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
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)
Body Temperature
Time frame: 1 week
Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Oxygen Saturation
Time frame: 1 week
Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
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.
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).
4 secondary outcomes
Pain intensity
Time frame: 1 week
Sleep quality
Time frame: 1 week
Patient Global Impression of Improvement
Time frame: 1 week
Pain condition-related medication usage
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 37582839Patterson 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.
- Individual participant dataSharing planned: Yes. Plan Description: De-identified individual participant data (IPD), including physiological parameters (heart rate variability, respiratory rate, blood pressure, oxygen saturation, skin temperature) and secondary outcomes (pain intensity scores, sleep quality assessments, medication intake, and patient global impression of improvement) will be shared with the Research Stimulus Group at Vrije Universiteit Brussel. The data will be used for real-time monitoring, statistical analysis, and preparation of scientific manuscripts related to this study. Access Criteria: Access to the IPD will be restricted to members of the Research Stimulus Group who are directly involved in the analysis and interpretation of the EPIC-DRG study data. Data handling will fully comply with GDPR regulations and institutional data protection policies. No public sharing of raw data is planned. Time Frame: Data will be transmitted continuously throughout the study period to enable interim analysis and monitoring, w
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dorsal root ganglion stimulation cessation in people with CRPS (Complex Regional Pain Syndrome) Type I, run by AZ Delta at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: 1 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.