Clinical trial NCT04692922: Prognostication of Recovery in Early Disorders of Consciousness Study
Official title: Prognostication of Recovery in Early Disorders of Consciousness Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Disorders of Consciousness Due to Severe Brain Injury
Keywords: Disorders of consciousness
Advanced neuroimaging
Neuroprognostication
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Disorders of consciousness following acute brain injury

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Glasgow Outcome Scale-Extended
timeFrame: 6 months following enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Brian L Edlow, MD
role: PRINCIPAL_INVESTIGATOR
References: