NeuralgiaECHONCT03386058
Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)
A study testing Temporary device deactivation in people with Neuralgia and Spinal Cord Stimulation, run by University of Aarhus at 10 sites in 6 countries.
Trial summary
Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment. The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Spinal Cord Stimulation
- What is being tested?
- Temporary device deactivation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 31 Jan 2018to 30 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient age minimum 18 years
- signed informed consent
- implanted with full SCS system for neuropathic pain
- SCS treatment duration minimum 6 months before inclusion
- maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device
Who cannot join
- any surgical SCS lead revision for the last 6 months before inclusion
- any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device
- any other ongoing neuromodulatory treatment (PNS, TENS, etc.)
- any other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days
- any changes in analgetic medication within the last 30 days (pn. dosings are allowed)
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8000
Odense University Hospital
Odense, 5230
Netherlands2 sites
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
Erasmus University Medical Center
Rotterdam, 3000CA
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Sunderby Hospital
Luleå, 97180
About this study
Official title: Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.
Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment.
The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads).
Read more
It is a well-known clinical observation that when activating or deactivating SCS stimulation, there is a variable interval before the patient perceives a clinical effect of the change. This variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. To our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients.
While patients may experience immediate pain relief at the onset of SCS treatment, the effect in patients with a long-term SCS treatment history may have different characteristics, possibly due to ongoing changes in the nervous system.
The aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation.
This will be carried out in a mixed population of patients with different indications for SCS, and with different treatment durations.
Patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion.
They will be asked to reactivate the device when specific parameters have been met, and the time is recorded.
Read the detailed description
In the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: Indication, treatment duration, symptom duration, preoperative pain score, stimulation paradigm, gender, age.
Data will be collected and stored using a dedicated REDCap database under the auspices of Aarhus University.
- Conditions
- Neuralgia, Spinal Cord Stimulation
- Being tested
- Temporary device deactivation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary device deactivationDevice
Patient-controlled, temporary deactivation of implanted device
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Temporary device deactivation Receives: Device: Temporary device deactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carryover/echo effect: Time from deactivation of device to cessation of treatment affect
Time from deactivation of device to cessation of treatment affect
Measured: Up to one week (may be repeated)
Secondary outcomes (1)
Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect
Time from reactivation of device to full reestablishment of treatment effect
Measured: Up to one week (may be repeated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start31 Jan 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, CHU de Quebec-Universite Laval, Medisch Spectrum Twente, Odense University Hospital, Aalborg University Hospital, Sahlgrenska University Hospital, Diakoniekrankenhaus Friederikenstift, Sunderby Hospital, Erasmus Medical Center, AZ Delta
- Responsible party
- Sponsor
- Investigators
- Kaare Meier, MD PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386058
- Sponsor's protocol ID
- SCS ECHO
- Acronym
- ECHO
- Status last verified
- Nov 2020
- First submitted
- 6 Dec 2017
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolter T, Winkelmuller M. Continuous versus intermittent spinal cord stimulation: an analysis of factors influencing clinical efficacy. Neuromodulation. 2012 Jan-Feb;15(1):13-9; discussion 20. doi: 10.1111/j.1525-1403.2011.00410.x. Epub 2011 Dec 12.
PubMed 22151660Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.
PubMed 23425338Meier K, de Vos CC, Bordeleau M, van der Tuin S, Billet B, Ruland T, Blichfeldt-Eckhardt MR, Winkelmuller M, Gulisano HA, Gatzinsky K, Knudsen AL, Hedemann Sorensen JC, Milidou I, Cottin SC. Examining the Duration of Carryover Effect in Patients With Chronic Pain Treated With Spinal Cord Stimulation (EChO Study): An Open, Interventional, Investigator-Initiated, International Multicenter Study. Neuromodulation. 2024 Jul;27(5):887-898. doi: 10.1016/j.neurom.2024.01.002. Epub 2024 Mar 7.
PubMed 38456888
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.
- ClinicalTrials.gov ID
- NCT03386058
- Acronym / sponsor ID
- ECHO / SCS ECHO
- Conditions
- Neuralgia, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, CHU de Quebec-Universite Laval, Medisch Spectrum Twente, Odense University Hospital, Aalborg University Hospital, Sahlgrenska University Hospital, Diakoniekrankenhaus Friederikenstift, Sunderby Hospital, Erasmus Medical Center, AZ Delta
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 29 Dec 2017 (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.
Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment.
The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads).
It is a well-known clinical observation that when activating or deactivating SCS stimulation, there is a variable interval before the patient perceives a clinical effect of the change. This variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. To our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients.
While patients may experience immediate pain relief at the onset of SCS treatment, the effect in patients with a long-term SCS treatment history may have different characteristics, possibly due to ongoing changes in the nervous system.
The aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation.
This will be carried out in a mixed population of patients with different indications for SCS, and with different treatment durations.
Patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion.
They will be asked to reactivate the device when specific parameters have been met, and the time is recorded.
Detailed description
In the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: Indication, treatment duration, symptom duration, preoperative pain score, stimulation paradigm, gender, age.
Data will be collected and stored using a dedicated REDCap database under the auspices of Aarhus University.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Temporary device deactivationTemporary device deactivation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient age minimum 18 years
- signed informed consent
- implanted with full SCS system for neuropathic pain
- SCS treatment duration minimum 6 months before inclusion
- maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device
Key exclusion criteria (5 listed)
- any surgical SCS lead revision for the last 6 months before inclusion
- any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device
- any other ongoing neuromodulatory treatment (PNS, TENS, etc.)
- any other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days
- any changes in analgetic medication within the last 30 days (pn. dosings are allowed)
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 |
|---|---|---|
| Temporary device deactivationPatient-controlled, temporary deactivation of implanted device | Device | Intervention |
Primary outcome
Carryover/echo effect: Time from deactivation of device to cessation of treatment affect
Time frame: Up to one week (may be repeated)
Time from deactivation of device to cessation of treatment affect
1 secondary outcome
Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect
Time frame: Up to one week (may be repeated)
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 13 May 2021.
- Background: PubMed 22151660Wolter T, Winkelmuller M. Continuous versus intermittent spinal cord stimulation: an analysis of factors influencing clinical efficacy. Neuromodulation. 2012 Jan-Feb;15(1):13-9; discussion 20. doi: 10.1111/j.1525-1403.2011.00410.x. Epub 2011 Dec 12.
- Background: PubMed 23425338Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.
- Derived from this study: PubMed 38456888Meier K, de Vos CC, Bordeleau M, van der Tuin S, Billet B, Ruland T, Blichfeldt-Eckhardt MR, Winkelmuller M, Gulisano HA, Gatzinsky K, Knudsen AL, Hedemann Sorensen JC, Milidou I, Cottin SC. Examining the Duration of Carryover Effect in Patients With Chronic Pain Treated With Spinal Cord Stimulation (EChO Study): An Open, Interventional, Investigator-Initiated, International Multicenter Study. Neuromodulation. 2024 Jul;27(5):887-898. doi: 10.1016/j.neurom.2024.01.002. Epub 2024 Mar 7.
- 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.
Kaare Meier, MD PhD principal investigator
Aarhus University Hospital
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary device deactivation in people with Neuralgia and Spinal Cord Stimulation, run by University of Aarhus at 10 sites in 6 countries.
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 5 inclusion and 5 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark, Netherlands, Sweden, Belgium, Canada and 1 more country. 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?
Carryover/echo effect: Time from deactivation of device to cessation of treatment affect (time frame: Up to one week (may be repeated)). 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 NCT03386058, which also lists 3 linked publications.
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 13 May 2021.