Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.

Conditions
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Neuralgia, Spinal Cord Stimulation

Intervention / Treatment
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* Device: Temporary device deactivation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Open study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Temporary device deactivation | Device: Temporary device deactivation<br>* Patient-controlled, temporary deactivation of implanted device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |