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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach

6 countries

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

December 6, 2017

Completed

23 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed

Last Updated

May 13, 2021

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

December 6, 2017

Last Update Submit

May 12, 2021

Conditions

Neuralgia Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect
Up to one week (may be repeated)

Study Arms (1)

Intervention

EXPERIMENTAL

Temporary device deactivation

Device: Temporary device deactivation

Interventions

Temporary device deactivationDEVICE

Patient-controlled, temporary deactivation of implanted device

Intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

patient age minimum 18 years
signed informed consent
implanted with full SCS system for neuropathic pain
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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Study Sites (10)

AZ Delta Roeselare/Menen/Torhout

Roeselare, 8800, Belgium

Location

CHU de Québec - Université Laval

Québec, Quebec, G1J 1Z6, Canada

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Odense University Hospital

Odense, 5230, Denmark

Location

Diakovera Friederikenstift

Hanover, 30169, Germany

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3000CA, Netherlands

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Sunderby Hospital

Luleå, 97180, Sweden

Location

Related Publications (3)

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.
PMID: 22151660BACKGROUND
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.
PMID: 23425338BACKGROUND
Meier K, de Vos CC, Bordeleau M, van der Tuin S, Billet B, Ruland T, Blichfeldt-Eckhardt MR, Winkelmuller M, Gulisano HA, Gatzinsky K, Knudsen AL, Hedemann Sorensen JC, Milidou I, Cottin SC. Examining the Duration of Carryover Effect in Patients With Chronic Pain Treated With Spinal Cord Stimulation (EChO Study): An Open, Interventional, Investigator-Initiated, International Multicenter Study. Neuromodulation. 2024 Jul;27(5):887-898. doi: 10.1016/j.neurom.2024.01.002. Epub 2024 Mar 7.
PMID: 38456888DERIVED

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Kaare Meier, MD PhD
Aarhus University Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 29, 2017

Study Start

January 31, 2018

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

May 13, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing: Will not share

Locations

CA(1)DE(1)DK(3)NL(2)BE(1)SE(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations