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Clinical Trials/NCT03504709
NCT03504709
Completed
Not Applicable

Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury

Massachusetts General Hospital1 site in 1 country79 target enrollmentSeptember 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Consciousness Disorder
Sponsor
Massachusetts General Hospital
Enrollment
79
Locations
1
Primary Endpoint
Disability Rating Scale total score
Status
Completed
Last Updated
last year

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
September 5, 2018
End Date
October 23, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian L. Edlow, M.D.

Neurocritical Care Faculty, Massachusetts General Hospital, Associate Director, Center for Neurotechnology and Neurorecovery (CNTR) Director, Laboratory for NeuroImaging of Coma and Consciousness (NICC)

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Disability Rating Scale total score

Time Frame: 6 months post injury

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.

Study Sites (1)

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