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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| CHU de Quebec-Universite Laval | OTHER |
| Medisch Spectrum Twente | OTHER |
| Odense University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Temporary device deactivation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary device deactivation | Device | Patient-controlled, temporary deactivation of implanted device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carryover/echo effect: Time from deactivation of device to cessation of treatment affect | Time from deactivation of device to cessation of treatment affect | Up to one week (may be repeated) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to one week (may be repeated) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kaare Meier, MD PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Delta Roeselare/Menen/Torhout | Roeselare | 8800 | Belgium | |||
| CHU de Québec - Université Laval |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22151660 | Background | 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. | |
| 23425338 | Background | 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. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| OTHER |
| Aalborg University Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Diakoniekrankenhaus Friederikenstift | OTHER |
| Sunderby Hospital | OTHER |
| Erasmus Medical Center | OTHER |
| AZ Delta | OTHER |
Open study
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| Québec |
| Quebec |
| G1J 1Z6 |
| Canada |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| Odense University Hospital | Odense | 5230 | Denmark |
| Diakovera Friederikenstift | Hanover | 30169 | Germany |
| Medisch Spectrum Twente | Enschede | Overijssel | 7512 KZ | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3000CA | Netherlands |
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Sunderby Hospital | Luleå | 97180 | Sweden |
| 38456888 | Derived | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |