Prognostication of Recovery in Early Disorders of Consciousness Study

Not yet recruiting

• Conditions: Disorders of Consciousness Due to Severe Brain Injury
• Interventions: Diagnostic Test: MRI; Diagnostic Test: EEG

• Registration Number: NCT04692922
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Study Start: 2025-08-01
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with disorders of consciousness	EEG	patients with a diagnosis of coma, vegetative state, or minimally conscious state minus (i.e. minimally conscious state without language function)
Patients with disorders of consciousness	MRI	patients with a diagnosis of coma, vegetative state, or minimally conscious state minus (i.e. minimally conscious state without language function)

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale-Extended	6 months following enrollment	Metric of neurologic function. The minimum score is 1, and the maximum score is 8. Higher scores represent less disability (8 represents non-disabling symptoms, 1 represents death).