Complex Regional Pain Syndrome Type ISTIMBURSTNCT05877612
Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs
An observational study of Complex Regional Pain Syndrome Type I, run by Elsan at 1 site in France.
Trial summary
In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I
- What is being tested?
- Implantable spinal cord stimulator
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2023to Sep 2025
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs, eligible for implantation of a medullary stimulator
Who may be able to join
- Patients between 18 and 75 years of age
- Patient with CRPS of at least one upper limb
- Patient affiliated to a Social Security plan
- Patient who has signed and dated the no-objection form
- Patient with the cognitive ability to understand the treatment and complete the questionnaires
- Patient who can be followed for a minimum of 1 year
Who cannot join
- Patient with an uncontrolled infection
- Pregnant or breastfeeding patient
- Patient who has already undergone treatment by spinal cord stimulation
- Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
- Patient who cannot be followed regularly for psychological, social, family or geographical reasons
- Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique BRETECHE
Nantes, 44046
Clinique BRETECHE, 0251868686
About this study
Official title: Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method
In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.
Read the detailed description
There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.
There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.
The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.
In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- Implantable spinal cord stimulator
- 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.
Implantable spinal cord stimulatorDevice
Spinal cord stimulation is possible thanks to implantable spinal cord neurostimulators. These are medical devices, which include a stimulation electrode and an implantable box, designed to deliver electrical stimulation for pain relief. The electrode is implanted in the epidural space in order to stimulate the posterior cords of the spinal cord through the dura mater, at the dorsal or cervical level.
| Study group | Role | What they receive |
|---|---|---|
| Burst stimulation | Patients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Receives: Device: Implantable spinal cord stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment at 3 months after implant
The analgesic outcome of spinal cord stimulation will be assessed by comparing the preoperative visual analogue pain scales (VAS) (ranging from 0: "No pain" to 100: "Maximum pain imaginable") to those performed at the 3rd month visit (3 months). Patients with a VAS score of 50% or more improvement will be considered "improved". The VAS value retained corresponds to the average of 3 values taken during the day (morning, noon and evening).
Measured: 3 months
Secondary outcomes (7)
procedure assesment
By using:
- VAS (ranging from 0: "No pain" to 100: "Maximum pain imaginable")
Measured: 1 month, 3 months, 6 months and 12 months
Assessing attention and working memory
By using:
- Trail Making Test (Reitan RM 1958) (2 parts A and B measured in seconds: The maximum score for part A is 100", 101" indicating that the test was not completed. The maximum score for Part B is 300", 301" indicating that the test was not completed)
Measured: 3 months and 12 months
qualitatively evaluate the effectiveness of the procedure
Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions.
Measured: 3 months
Medication use
Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used)
Measured: 1 month, 3 months, 6 months and 12 months
procedure assesment
By using:
- Hospital Anxiety and Depression scale (HAD) (Mykletun A 2001) (2 columns ranging from 0 " no or few anxiety" to 21 "high anxiety"
Measured: 1 month, 3 months, 6 months and 12 months
procedure assesment
By using:
- Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good")
Measured: 1 month, 3 months, 6 months and 12 months
Assessing attention and working memory
By using:
- WAIS-IV (Benson N 2010) ( 4 subtests submited with 10 items in all (ranging 0 to 19 each), to calculate intelligence quotient with a minimum at 0 and a maximum at 190)
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start12 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Jean-Paul NGUYEN, Prof, Study director, Clinique Bretéché ELSANSylvain DURAND, Dr, Principal investigator, Clinique Bretéché ELSAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877612
- Sponsor's protocol ID
- 2023-A00638-37
- Acronym
- STIMBURST
- Status last verified
- Sep 2023
- First submitted
- 5 May 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method
- ClinicalTrials.gov ID
- NCT05877612
- Acronym / sponsor ID
- STIMBURST / 2023-A00638-37
- Conditions
- Complex Regional Pain Syndrome Type I
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 26 May 2023 (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.
In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.
Detailed description
There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.
There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.
The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.
In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burst stimulation | – | Device: Implantable spinal cord stimulatorPatients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs, eligible for implantation of a medullary stimulator
Key inclusion criteria (6 listed)
- Patients between 18 and 75 years of age
- Patient with CRPS of at least one upper limb
- Patient affiliated to a Social Security plan
- Patient who has signed and dated the no-objection form
- Patient with the cognitive ability to understand the treatment and complete the questionnaires
Key exclusion criteria (6 listed)
- Patient with an uncontrolled infection
- Pregnant or breastfeeding patient
- Patient who has already undergone treatment by spinal cord stimulation
- Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
- Patient who cannot be followed regularly for psychological, social, family or geographical reasons
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 |
|---|---|---|
| Implantable spinal cord stimulatorSpinal cord stimulation is possible thanks to implantable spinal cord neurostimulators. These are medical devices, which include a stimulation electrode and an implantable box, designed to deliver electrical stimulation for pain relief. The electrode is implanted in the epidural space in order to stimulate the posterior cords of the spinal cord through the dura mater, at the dorsal or cervical level. | Device | Burst stimulation |
Primary outcome
Pain assessment at 3 months after implant
Time frame: 3 months
The analgesic outcome of spinal cord stimulation will be assessed by comparing the preoperative visual analogue pain scales (VAS) (ranging from 0: "No pain" to 100: "Maximum pain imaginable") to those performed at the 3rd month visit (3 months). Patients with a VAS score of 50% or more improvement will be considered "improved". The VAS value retained corresponds to the average of 3 values taken during the day (morning, noon and evening).
7 secondary outcomes
procedure assesment
Time frame: 1 month, 3 months, 6 months and 12 months
Assessing attention and working memory
Time frame: 3 months and 12 months
qualitatively evaluate the effectiveness of the procedure
Time frame: 3 months
Medication use
Time frame: 1 month, 3 months, 6 months and 12 months
procedure assesment
Time frame: 1 month, 3 months, 6 months and 12 months
procedure assesment
Time frame: 1 month, 3 months, 6 months and 12 months
Assessing attention and working memory
Time frame: 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Jean-Paul NGUYEN, Prof study director
Clinique Bretéché ELSAN
Sylvain DURAND, Dr principal investigator
Clinique Bretéché ELSAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndrome Type I, run by Elsan at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent WYART, MSc (0240958176, vincent.wyart@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment at 3 months after implant (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2023.