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Completed

NCT Number: NCT04319887

ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.

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Key information

Conditions

Chronic Pain Back Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has chronic intractable pain of the trunk and/or limbs.
  • Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion criteria

  • Subject is unable to operate the system.
  • Subject is an unsuitable surgical candidate.
  • Subject has a condition currently requiring or likely to require the use of diathermy.
  • Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
  • Subject is <18 years old.
  • Subject is pregnant or nursing.
  • Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
  • Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).

Treatment and study plan

Evoke Spinal Cord Stimulation (SCS) System

Device

A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Primary outcomes

  1. Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System

    Time frame: 12-months post-implant

    Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.

Other outcomes

  1. Change in Pain

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

    Visual Analogue Scale (VAS) to rate pain intensity

  2. Change in PROMIS-29

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

    29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.

  3. Change in PROMIS-10 Global

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

    10-item instrument that assesses Physical Health and Mental Health

  4. Change in Profile of Mood States (POMS 2-A Short)

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

    35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness.

  5. Rate of Patient Global Impression of Change (PGIC)

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

    Single item measure of global improvement with treatment

  6. Rate of Patient Satisfaction With Therapy

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

    Single item measure of satisfaction with treatment

Sponsors and collaborators

Lead sponsor

Saluda Medical Pty Ltd

Industry

Registry information

Official study title

A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Acronym: ECAP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2020
Registry last updated
Dec 31, 2024

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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