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

Completed

• Conditions: Brain Injuries, Traumatic; Consciousness Disorder; Coma

• Registration Number: NCT03504709
• Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Study Start: 2018-09-05
• Primary Completion: 2023-07-19
• Study Completion: 2023-10-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States