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

NCT07267715 | Not Yet Recruiting FDA Device

• 1 other identifier: 250714-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Treatment of chronic pain of the trunk and/or limbs.

Outcome Measures

Primary Outcomes (1)

• Evoke® therapy neural panel metrics generated by EVA™

  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 Outcomes (3)

• Pain Locus of Control

  Up to 30 days

• Numeric Rating Scale

  Up to 30 days

• PROMIS-29+2

  Up to 30 days

Study Arms (1)

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

Interventions

Spinal Cord Stimulation (SCS) System DEVICE

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.

SCS Evoke System Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Saluda Medical Pty Ltd: collaborator
• Dustin Reynolds, MD: lead

Study Sites (1)

Mount Carmel Health System

Columbus, Ohio, 43054, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drug Therapy

Study Officials

• Dustin Reynolds, MD

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa B. Showe

CONTACT

1-614-775-6607; melissa.showe@mchs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Pain Management Specialist, Anesthesiologist

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

US (1)