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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03504709

Acronym

RESPONSE 2

Enrollment

Registered

2018-04-20

Start date

2018-09-05

Completion date

2023-10-23

Last updated

2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic, Coma, Consciousness Disorder

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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:

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results