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

Mass General Brigham

Status: Completed

Conditions: Coma; Consciousness Disorder; Brain Injuries, Traumatic

Study type: Observational

Funder types: Other

Identifiers

NCT03504709

2012P000784

Details and patient eligibility

About

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).

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

79 participants in 2 patient groups

Patient (n=50)

Description:

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)

Description:

Healthy adults with no neurological, psychiatric, or medical disease.