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

Dustin Reynolds, MD

Status

Not yet enrolling

Conditions

Chronic Pain

Treatments

Device: Spinal Cord Stimulation (SCS) System

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07267715

250714-1

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.