Идёт набор NCT04639297

NeuroVision vs Standard Neuromonitoring

Без фазы С лечением Neurologic Deficits

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: NeuroVision® IONM, Hospital Based IONM.
Кому может быть актуально: Состояния в реестре: Neurologic Deficits. Базовые параметры: Без ограничений · 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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Официальное название

NeruoVision Versus Standard Hospital Neuromonitoring, Influence on the Rate of Neurologic Injury Following Spine Surgery? A Randomized Controlled Trial

Обзор

The purpose of this study is to perform a prospective, randomized, controlled clinical trial to assess the utility of IONM in patients undergoing primary, single or multilevel lateral spinal procedures. Subjects will be randomized to undergo a lateral spine surgery with the use of NeuroVision® IONM or conventional hospital based IONM to assess incidence of new-onset neurological injury.

Подробное описание

Elective spinal surgery for the correction of degenerative spinal pathology may involve significant intraoperative risks that can influence postoperative neurologic outcomes. Spinal cord monitoring had made it possible to track the spine and nerve root sensory and motor tracts. This has improved the ability to conduct minimally invasive surgery by allowing surgeons to operate without direct visualization of the neurologic elements.

Intraoperative neuromonitoring (IONM) of the spinal cord is primarily accomplished by both somatosensory evoked potentials (SSEP) and transcranial motor evoked potentials (tcMEPs). Due to a shortage in personnel trained to evaluate neuro-monitoring results, surgeon-driven systems have been established. An example of a surgeon driven monitoring system is NeuroVision®, which interacts with the surgeon during the operation by providing real-time visible and auditory tcMEP and compound muscle action potential (CMAP) waveforms. This stands in comparison to hospital based methods of IONM.

Вмешательства

Устройство NeuroVision® IONM
Using NeuroVision® prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
Устройство Hospital Based IONM
Using hospital based IONM prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.

Первичные конечные точки

Incidence of new-onset neurological injury [Срок оценки: Enrollment up to 2 years postoperatively]

Вторичные конечные точки (3)

Cost analysis of IONM use [Срок оценки: Enrollment up to 1 month post-operative]
False positive and false negative events in each modality [Срок оценки: Intraoperatively up to 1 day post-operative]
Adverse Events [Срок оценки: Postoperative to documented progress assessed up to 2 months]

Критерии участия

Критерии включения

Patients undergoing a primary single or multilevel lateral spinal surgery procedures for degenerative pathology Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, central stenosis, foraminal stenosis herniated nucleus pulposus, degenerative disc disease, spondylosis, and osteophytic complexes
Patients able to provide informed consent