Prognostication of Recovery in Early Disorders of Consciousness Study

Обзор

By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 6 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

Подробное описание

The primary aim of this research proposal is as follows: By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 3, 6, and 12 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

There will also be secondary aims as follows:

1. To identify patient phenotypes with predictive significance, in order to revise our classification scheme for disorders of consciousness in a clinically meaningful and data driven manner. 2. To compare prognostic value between metrics. 3. To determine how the initial goals of care expressed in the acute setting (i.e., the expected quality of life associated with disability) compare to the actual quality of life in the chronic setting (i.e., the actual quality of life associated with disability). 4. To compare the prognostic value of metrics between different etiologies of brain injury.

Вмешательства

• Диагностический тест MRI
  MRI will include structural sequences (e.g., T1 weighted imaging, T2 weighted imaging, T2 FLAIR, diffusion weighted imaging with apparent diffusion coefficient, susceptibility weighted imaging, and diffusion tensor imaging). Using the structural sequences we will make note of the types of brain lesions (e.g., ischemic stroke, hemorrhage, hypoxic-ischemic brain injury), and the locations of these brain lesions. MRI will also include fMRI under three conditions: while the patient is at rest (to ev
• Диагностический тест EEG
  The EEG will include resting, stimulus-based, and task-based assessments of brain function.

Первичные конечные точки

• Glasgow Outcome Scale-Extended [Срок оценки: 6 months following enrollment]

Критерии участия

Критерии включения

• Acute brain injury (including ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, encephalitis)
• Inability to follow commands, speak intelligibly, or communicate (i.e., diagnosis of coma, vegetative state, or minimally conscious state minus) due to the underlying brain injury and within 28 days of the brain injury
• Age 18 or greater.

Критерии исключения

• Subjects will be excluded if they do not speak English (given the reliance on verbal questionnaires conducted in English) or if they regain the ability to follow commands, speak intelligibly or communicate (i.e., improves to minimally conscious state plus or greater) before they undergo MRI or EEG.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04692922 · 2020P002706

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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