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Набор по приглашению NCT07074678

Prognostication of Recovery in Early Disorders of Consciousness Study

Без фазы С лечением Disorder of Consciousness Comatose Coma; Prolonged Vegetative State

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: Functional MRI (fMRI).
Кому может быть актуально
Состояния в реестре: Disorder of Consciousness, Comatose, Coma; Prolonged, Vegetative State. 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 goal of this study is to determine the extent to which neuroimaging metrics (e.g., functional MRI) are associated with the current level of consciousness, and future consciousness recovery, in patients with disorders of consciousness resulting from acute brain injury. The main questions this study aims to answer are: How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with current level of consciousness? How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with future recovery of consciousness? How does noxious stimulation affect the detection of covert consciousness and functional brain network connectivity?

Подробное описание

Patients with disorders of consciousness (lacking overt signs of consciousness such as command-following) due to acute brain injury will be identified and enrolled via the Recovery of Consciousness Via Evidence-Based Medicine and Research (RECOVER) Program. Patients in the study will undergo a detailed behavioral consciousness assessment (with the Coma Recovery Scale - Revised \[CRS-R\]), conducted by specially trained personnel, as well as a task-based functional MRI with auditory stimulation (motor commands) to assess for technologic covert consciousness (the willful modulation of brain activity to command) and functional brain network connectivity. For a subset of patients, the functional MRI will be performed with and without noxious stimulation, during the same scanning session. Patients will undergo repeat behavioral evaluations at hospital discharge, and 3 and 6 months after, to assess for overt consciousness recovery.

Вмешательства

  • Диагностический тест Functional MRI (fMRI)
    Research MRI, which will include both structural and functional sequences, will either be collected independently, or in conjunction with clinically-indicated sequences. Functional MRI captures the blood oxygen level dependent (BOLD) signal that reflects brain activity. A subset of the PREDICT study fMRI will include sequences with auditory and/or noxious stimulation. Noxious stimulation will be delivered with an MRI-compatible device that delivers intermittent nailbed pressure under computerize

Первичные конечные точки

  • Detection of technologic covert consciousness [Срок оценки: Baseline, during hospitalization (estimated approximately 1 month from brain injury)]
  • Functional network connectivity [Срок оценки: Baseline, during hospitalization (estimated approximately 1 month from brain injury)]
  • Detection of behavioral covert consciousness [Срок оценки: Baseline, during hospitalization (estimated approximately 1 month from brain injury), within 24 hours of the functional MRI]
  • Overt consciousness recovery based on Disability Rating Scale [Срок оценки: Through study completion: At hospital discharge (estimated approximately 1 month from brain injury), 3 months after hospital discharge, and 6 months after hospital discharge]

Критерии участия

For patients:

Критерии включения

  • Acute brain injury (including, but not limited to ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, or encephalitis)
  • Inability to follow commands due to a disorder of consciousness (comatose, vegetative, or minimally conscious state) caused by the underlying brain injury
  • Age 18 or greater
  • Enrolled within 28 days of brain injury

Критерии исключения

  • Imminent death (as indicated, for example, by planned transition to palliative measures, brain death testing, or severe medical instability)
  • MRI contraindications would exclude patients from imaging component of study

For healthy controls:

Критерии исключения

  • MRI contraindications
  • History of brain injury to neurological disease
  • History of diabetes, high blood pressure, kidney disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Hospital of the University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07074678 · 852381 · 1K23NS136745-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗