Skip to main content
OpenTrials
Completed

NCT Number: NCT03504709

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Consciousness Disorder Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Coma Consciousness Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Unconsciousness Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: RESPONSE 2

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2018
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.