RESPONSE 2: REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03504709

Collaborator

(none)

Enrollment

Location

109.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Consciousness Disorder Coma Brain Injuries, Traumatic

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 5, 2018

Anticipated Primary Completion Date :

Sep 5, 2022

Anticipated Study Completion Date :

Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Patient (n=50) Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post injury.
Healthy (n=25) Healthy adults with no neurological, psychiatric, or medical disease.

Outcome Measures

Primary Outcome Measures

Disability Rating Scale total score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT03504709

Other Study ID Numbers: