Clinical trial NCT03386058: Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)
Official title: Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgia
Spinal Cord Stimulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: CHU de Quebec-Universite Laval
name: Medisch Spectrum Twente
name: Odense University Hospital
name: Aalborg University Hospital
name: Sahlgrenska University Hospital
name: Diakoniekrankenhaus Friederikenstift
name: Sunderby Hospital
name: Erasmus Medical Center
name: AZ Delta
First posted: 2017-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open study
Primary purpose: BASIC_SCIENCE

Brief 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) 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

* 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)

Primary outcomes:
measure: Carryover/echo effect: Time from deactivation of device to cessation of treatment affect
timeFrame: Up to one week (may be repeated)
Secondary outcomes:
measure: Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect
timeFrame: Up to one week (may be repeated)
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta Roeselare/Menen/Torhout
city: Quebec City
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Hannover
country: Germany
facility: Diakovera Friederikenstift
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Luleå
country: Sweden
facility: Sunderby Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Kaare Meier, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.