EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA

November 25, 2025 updated by: Dustin Reynolds, MD

The Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments.

This research registry is being conducted to collect data from patients treated with a SCS device in order to determine how the device impacts their chronic pain condition.

Specifically, the study aims to:

  • Evaluate data collected from the SCS system on how well the system is working.
  • Evaluate the feasibility of programming the SCS system independently without external assistance.
  • Evaluate changes in physical function, fatigue, pain interference, mood, sleep, daily activities, pain control, and overall satisfaction with the device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43054
        • Mount Carmel Health System
        • Contact:
        • Principal Investigator:
          • Dustin Reynolds, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with chronic, intractable focal pain of the trunk and/or limbs will be screened for participation in this study. Subjects who provide informed consent and meet the eligibility criteria will be enrolled and will undergo a trial procedure. Following the trial phase subjects may receive a permanent implant. Enrollment will continue until 30 subjects receive a permanent implant. We estimate that up to 40 subjects will be enrolled in this registry.

Description

Inclusion Criteria:

  • Subject is not pregnant and 18 years of age or older at the time of enrollment.
  • Subject has a minimum NRS score of 6 or higher (where 10 indicates the worst imaginable pain) in primary area of pain at baseline.
  • Subject is planning to have a temporary trial with the Evoke® System to aid in the management of chronic intractable pain of the trunk and/or limbs.
  • Subject is willing to program the Evoke® System using EVA™ under the supervision of the study investigator or Qualified Health Professional.
  • Subject is being trialed with a neurostimulation system for the first time.
  • Subject is able to read and understand English.
  • Subject is capable of subjective evaluation; subject must be able to describe and rate his/her pain levels.
  • Subject is willing and capable of giving informed consent.
  • Subject is willing and able to comply with study-related requirements, procedures, and visits.
  • Subject has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator.

Exclusion Criteria:

- There are no exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SCS Evoke System Implant
Subjects with chronic, intractable focal pain of the trunk and/or limbs who undergo Evoke System implant.
Device: Spinal Cord Stimulation (SCS) System
Spinal cord stimulation system as an aid in the management of chronic intractable pain of the trunk and/or limbs; and will be used within its commercially approved indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evoke® therapy neural panel metrics generated by EVA™
Time Frame: At time of EVA programming and through study completion (up to 30 days)
The core neural panel metric generated by the Saluda Medical Evoke® therapy system, specifically via its EVA™ sensing technology, is the Evoked Compound Action Potential (ECAP). ECAPs are objective neurophysiological biomarkers that represent the spinal cord's electrical response to stimulation.
At time of EVA programming and through study completion (up to 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Locus of Control
Time Frame: Up to 30 days
The PLOC classifies the location in which individuals realize predominantly who or what stops the control of their pain. Factor analysis of the main components of this new scale revealed four dimensions: internal LC, chance LC, other people LC (friends and family), doctor and health professional LC. PLOC will be measured using an adapted version of a general purpose, condition-specific Multidimensional Health Locus of Control (MHLC) scale. The responses will be shortened from 6-level to 4-level: strongly agree, agree, disagree and strongly disagree. Each subscale receives an independent score, ranging from 6 to 24 (internal and chance LC subscales) and from 3 to 12 (health professionals and others LC subscales).
Up to 30 days
Numeric Rating Scale
Time Frame: Up to 30 days
The NRS is a subjective measure of pain. It is a commonly used pain assessment tool where individuals rate their pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. It's a simple, quick, and widely accepted method for quantifying pain intensity.
Up to 30 days
PROMIS-29+2
Time Frame: Up to 30 days
The PROMIS-29+2 consists of the PROMIS-29 profile (v2.1) and two PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 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.
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dustin Reynolds, MD

Collaborators

Saluda Medical Pty Ltd

Investigators

  • Principal Investigator: Dustin Reynolds, MD, Mount Carmel Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250714-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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