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

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ClinicalTrials.gov Identifier: NCT03386058
Recruitment Status : Enrolling by invitation
First Posted : December 29, 2017
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
Aarhus University Hospital
CHU de Quebec-Universite Laval
Medisch Spectrum Twente
Odense University Hospital
Aalborg Universitetshospital
Sahlgrenska University Hospital, Sweden
University Health Network, Toronto
Diakovera Friederikenstift Hannover
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Neuralgia Spinal Cord Stimulation Device: Temporary device deactivation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386058


Locations
Canada, Ontario
Toronto Western Hospital, Department of Anesthesia and Pain Medicine
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
CHU de Québec - Université Laval
Quebec City, Quebec, Canada, G1J 1Z6
Denmark
Aalborg University Hospital
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus, Denmark, 8000
Odense University Hospital
Odense, Denmark, 5230
Germany
Diakovera Friederikenstift
Hannover, Germany, 30169
Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7512 KZ
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 413 45
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
CHU de Quebec-Universite Laval
Medisch Spectrum Twente
Odense University Hospital
Aalborg Universitetshospital
Sahlgrenska University Hospital, Sweden
University Health Network, Toronto
Diakovera Friederikenstift Hannover
Investigators
Principal Investigator: Kaare Meier, MD PhD Aarhus University Hospital

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03386058     History of Changes
Other Study ID Numbers: SCS ECHO
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms