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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 : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : January 22, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Neuralgia Spinal Cord Stimulation Device: Temporary device deactivation

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 Design

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.
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
Contacts and Locations

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


Contacts
Contact: Kaare Meier, MD PhD +45 2499 5034 neuro@kaare.org

Locations
Canada, Ontario
Toronto Western Hospital, Department of Anesthesia and Pain Medicine Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Anuj Bhatia, MD    +1 416 603 5118    anuj.bhatia@uhn.ca   
Contact: Yasmine Hoydonckx, MD    +1 416 603 5118    yasmine.hoydonckx@one-mail.on.ca   
Principal Investigator: Anuj Bhatia, MD         
Sub-Investigator: Yasmine Hoydonckx, MD         
Canada, Quebec
CHU de Québec - Université Laval Not yet recruiting
Quebec City, Quebec, Canada, G1J 1Z6
Contact: Sylvine C Cottin, PhD       sylvine.cottin-carrondo@crchudequebec.ulaval.ca   
Sub-Investigator: Sylvine C Cottin, PhD         
Principal Investigator: Michel Prud'Homme, MD PhD         
Sub-Investigator: Martine Bordeleau, MSc         
Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, 9000
Contact: Helga A Gulisano, MD MPG    +45 97 66 24 70    heang@rn.dk   
Contact: Elin Eriksen, RN MHH       ele@rn.dk   
Principal Investigator: Helga A Gulisano, MD MPG         
Sub-Investigator: Elin Eriksen, RN MHH         
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Kaare Meier, MD PhD    +45 2499 5034    neuro@kaare.org   
Sub-Investigator: Anne Lene H Knudsen, RN         
Sub-Investigator: Jens Chr. H Sørensen, MD PhD DMSc         
Principal Investigator: Kaare Meier, MD PhD         
Odense University Hospital Not yet recruiting
Odense, Denmark, 5230
Contact: Morten Rune Blichfeldt-Eckhardt, MD PhD    +4565414721    mr.be@rsyd.dk   
Contact: Christian Scherer, MD    +4565412553    christian.scherer@rsyd.dk   
Principal Investigator: Morten Rune Blichfeldt-Eckhardt, MD PhD         
Sub-Investigator: Christian Scherer, MD         
Netherlands
Medisch Spectrum Twente Not yet recruiting
Enschede, Overijssel, Netherlands, 7512 KZ
Contact: Cecile C de Vos, PhD    +31 53 487 2840    c.devos@mst.nl   
Contact: Mathieu W Lenders, MD    +31 53 487 2840    m.lenders@mst.nl   
Principal Investigator: Cecile C de Vos, PhD         
Sub-Investigator: Mathieu W Lenders, MD         
Sweden
Sahlgrenska University Hospital Not yet recruiting
Göteborg, Sweden, 413 45
Contact: Kliment Gatzinsky, MD PhD    +46733407733    kliment.gatzinsky@neuro.gu.se   
Principal Investigator: Kliment Gatzinsky, MD PhD         
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
Investigators
Principal Investigator: Kaare Meier, MD PhD Aarhus University Hospital
More Information

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: January 22, 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