Prognostication of Recovery in Early Disorders of Consciousness Study

NCT04692922 | Not Yet Recruiting

• 1 other identifier: 2020P002706
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Keywords

Disorders of consciousness; Advanced neuroimaging; Neuroprognostication

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale-Extended

  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).

  6 months following enrollment

Study Arms (1)

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)

Diagnostic Test: MRI; Diagnostic Test: EEG

Interventions

MRI 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).

Patients with disorders of consciousness

EEG DIAGNOSTIC_TEST

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

Patients with disorders of consciousness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Disorders of consciousness following acute brain injury

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Brian L Edlow, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Fischer, MD

CONTACT

617-724-6352; DFISCHER2@mgh.harvard.edu

Yelena Bodien, PhD

CONTACT

ybodien@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: January 5, 2021
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: April 24, 2026

Record last verified: 2026-04