Набор скоро начнётся NCT07267715

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

— Наблюдательное Chronic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Spinal Cord Stimulation (SCS) System.
Кому может быть актуально: Состояния в реестре: Chronic Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

Pain Locus of Control [Срок оценки: Up to 30 days]
Numeric Rating Scale [Срок оценки: Up to 30 days]
PROMIS-29+2 [Срок оценки: Up to 30 days]

Критерии участия

Критерии включения

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.