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

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.

Conditions

• Neuralgia
• Spinal Cord Stimulation

Interventions

DEVICE

Temporary device deactivation

Patient-controlled, temporary deactivation of implanted device

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Diakoniekrankenhaus Friederikenstift

  collaborator OTHER

• Sunderby Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Kaare Meier, MD PhD · Aarhus University Hospital

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-31

Primary Completion

2021-03-30

Completion

2021-03-30

Countries

• Belgium
• Canada
• Denmark
• Germany
• Netherlands
• Sweden

Study Locations