Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)
NCT ID: NCT03386058
Last Updated: 2021-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2018-01-31
2021-03-30
Brief Summary
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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.
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Detailed Description
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Data will be collected and stored using a dedicated REDCap database under the auspices of Aarhus University.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Intervention
Temporary device deactivation
Temporary device deactivation
Patient-controlled, temporary deactivation of implanted device
Interventions
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Temporary device deactivation
Patient-controlled, temporary deactivation of implanted device
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
CHU de Quebec-Universite Laval
OTHER
Medisch Spectrum Twente
OTHER
Odense University Hospital
OTHER
Aalborg University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Diakoniekrankenhaus Friederikenstift
OTHER
Sunderby Hospital
OTHER
Erasmus Medical Center
OTHER
AZ Delta
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kaare Meier, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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AZ Delta Roeselare/Menen/Torhout
Roeselare, , Belgium
CHU de Québec - Université Laval
Québec, Quebec, Canada
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Odense University Hospital
Odense, , Denmark
Diakovera Friederikenstift
Hanover, , Germany
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Sahlgrenska University Hospital
Gothenburg, , Sweden
Sunderby Hospital
Luleå, , Sweden
Countries
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References
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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.
Perruchoud 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.
Meier 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.
Other Identifiers
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SCS ECHO
Identifier Type: -
Identifier Source: org_study_id
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