EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Cord Stimulation (SCS) System.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Evoke® therapy neural panel metrics generated by EVA™ [Time frame: At time of EVA programming and through study completion (up to 30 days)]
Secondary outcome measures (3)
- Pain Locus of Control [Time frame: Up to 30 days]
- Numeric Rating Scale [Time frame: Up to 30 days]
- PROMIS-29+2 [Time frame: Up to 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mount Carmel Health System — Columbus
Identifiers
NCT: NCT07267715 · 250714-1