Prognostication of Recovery in Early Disorders of Consciousness Study

NCT ID: NCT04692922

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-30

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.

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with disorders of consciousness

patients with a diagnosis of coma, vegetative state, or minimally conscious state minus (i.e. minimally conscious state without language function)

MRI

Intervention Type: DIAGNOSTIC_TEST

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 evaluate resting state functional connectivity), while the patient is exposed to auditory stimuli (to evaluate passive fMRI responses to stimuli), and while the patient is asked to follow commands (to evaluate active fMRI responses to tasks).

EEG

Intervention Type: DIAGNOSTIC_TEST

The EEG will include resting, stimulus-based, and task-based assessments of brain function.

Interventions

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 evaluate resting state functional connectivity), while the patient is exposed to auditory stimuli (to evaluate passive fMRI responses to stimuli), and while the patient is asked to follow commands (to evaluate active fMRI responses to tasks).

Intervention Type: DIAGNOSTIC_TEST

EEG

The EEG will include resting, stimulus-based, and task-based assessments of brain function.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brian L. Edlow, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian L Edlow, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Central Contacts

David Fischer, MD

Role: CONTACT

DFISCHER2@mgh.harvard.edu

617-724-6352

Yelena Bodien, PhD

Role: CONTACT

ybodien@mgh.harvard.edu

Other Identifiers

2020P002706

Identifier Type: -

Identifier Source: org_study_id