Prognostication of Recovery in Early Disorders of Consciousness Study (PREDICT)

• ClinicalTrials.gov Identifier: NCT04692922
• Recruitment Status: Not yet recruiting
• First Posted: January 5, 2021
• Last Update Posted: February 2, 2022
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Brian L. Edlow, M.D., Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Disorders of Consciousness Due to Severe Brain Injury	Diagnostic Test: MRI; Diagnostic Test: EEG

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 Design

• Study Type: Observational
• Estimated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prognostication of Recovery in Early Disorders of Consciousness Study
• Estimated Study Start Date: August 1, 2022
• Estimated Primary Completion Date: July 30, 2025
• Estimated Study Completion Date: July 30, 2025

Groups and Cohorts

Group/Cohort

Intervention/treatment

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; 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).; Diagnostic Test: EEG; The EEG will include resting, stimulus-based, and task-based assessments of brain function.

Outcome Measures

Primary Outcome Measures :

1. Glasgow Outcome Scale-Extended [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Disorders of consciousness following acute brain injury

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.

Contacts and Locations

Contacts

Contact: David Fischer, MD; 617-724-6352; DFISCHER2@mgh.harvard.edu

Contact: Yelena Bodien, PhD; ybodien@mgh.harvard.edu

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Brian L Edlow, MD; Massachusetts General Hospital

More Information

• Responsible Party: Brian L. Edlow, M.D., Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04692922
• Other Study ID Numbers: 2020P002706
• First Posted: January 5, 2021
• Last Update Posted: February 2, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian L. Edlow, M.D., Massachusetts General Hospital:

Disorders of consciousness; Advanced neuroimaging; Neuroprognostication

Additional relevant MeSH terms:

Brain Injuries; Consciousness Disorders; Disease; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Neurocognitive Disorders; Mental Disorders