REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness

Massachusetts General Hospital79 enrolled

Overview

The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Consciousness Disorder Coma Brain Injuries, Traumatic

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Patients: Inclusion Criteria: * Traumatic Brain Injury * Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness * Clinical evidence of disorder of consciousness defined as coma, VS, or MCS Exclusion Criteria: * History of prior severe brain injury or dementia * Emergence from MCS at time of initial CRS-R assessment Healthy Subjects: Exclusion Criteria: History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Disability Rating Scale total score

The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening \[score range 0-3\], communication \[score range 0-4\], motor response \[score range 0-5\], cognitive ability for feeding \[score range 0-3\], cognitive ability for toileting \[score range 0-3\], cognitive ability for grooming \[score range 0-3\], level of function \[score range 0-5\], and employability \[score range 0-3\]. Subscale scores are summed to produce the total score.

Time frame: 6 months post injury

Data from ClinicalTrials.gov

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