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

May 12, 2021 updated by: University of Aarhus

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Roeselare, Belgium, 8800
        • AZ Delta Roeselare/Menen/Torhout
  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1J 1Z6
        • CHU de Quebec - Universite Laval
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Odense, Denmark, 5230
        • Odense University Hospital
  • Germany
      • Hannover, Germany, 30169
        • Diakovera Friederikenstift
  • Netherlands
      • Rotterdam, Netherlands, 3000CA
        • Erasmus University Medical Center
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7512 KZ
        • Medisch Spectrum Twente
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Luleå, Sweden, 97180
        • Sunderby Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Temporary device deactivation
Device: Temporary device deactivation
Patient-controlled, temporary deactivation of implanted device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Frame: Up to one week (may be repeated)
Time from reactivation of device to full reestablishment of treatment effect
Up to one week (may be repeated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Odense University Hospital
Aarhus University Hospital
CHU de Quebec-Universite Laval
Erasmus Medical Center
Sahlgrenska University Hospital, Sweden
AZ Delta
Sunderby Hospital
Aalborg University Hospital
Medisch Spectrum Twente
Diakoniekrankenhaus Friederikenstift

Investigators

  • Principal Investigator: Kaare Meier, MD PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCS ECHO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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