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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Dustin Reynolds, MD
Study ID
NCT07267715
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: SCS Evoke System Implant
    Subjects with chronic, intractable focal pain of the trunk and/or limbs who undergo Evoke System implant.

Primary Outcome Measure

Evoke® therapy neural panel metrics generated by EVA™ [ Time Frame: At time of EVA programming and through study completion (up to 30 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Carmel Health SystemColumbusOhio43054
Cameron Rink, PhD, MBA
[email protected]
614-546-4518
Dustin Reynolds, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Carmel Health System· Columbus, OH

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