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NCT Number: NCT03386058

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

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.

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Key information

Conditions

Neuralgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Stimulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Delta Roeselare/Menen/Torhout, Roeselare, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Temporary device deactivation

Device

Patient-controlled, temporary deactivation of implanted device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO). An Open, Prospective, Multicenter Study.

Acronym: ECHO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2017
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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