By InvitationNot Applicable

Prognostication of Recovery in Early Disorders of Consciousness Study

United States150 participantsStarted 2023-03-08

Plain-language summary

The goal of this study is to determine the extent to which neuroimaging metrics (e.g., functional MRI) are associated with the current level of consciousness, and future consciousness recovery, in patients with disorders of consciousness resulting from acute brain injury. The main questions this study aims to answer are: How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with current level of consciousness? How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with future recovery of consciousness? How does noxious stimulation affect the detection of covert consciousness and functional brain network connectivity?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

For patients: Inclusion Criteria: * Acute brain injury (including, but not limited to ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, or encephalitis) * Inability to follow commands due to a disorder of consciousness (comatose, vegetative, or minimally conscious state) caused by the underlying brain injury * Age 18 or greater * Enrolled within 28 days of brain injury Exclusion Criteria: * Imminent death (as indicated, for example, by planned transition to palliative measures, brain death testing, or severe medical instability) * MRI contraindications would exclude patients from imaging component of study For healthy controls: Exclusion Criteria: * MRI contraindications * History of brain injury to neurological disease * History of diabetes, high blood pressure, kidney disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detection of technologic covert consciousness

Timeframe: Baseline, during hospitalization (estimated approximately 1 month from brain injury)

Functional network connectivity

Timeframe: Baseline, during hospitalization (estimated approximately 1 month from brain injury)

Detection of behavioral covert consciousness

Timeframe: Baseline, during hospitalization (estimated approximately 1 month from brain injury), within 24 hours of the functional MRI

Overt consciousness recovery based on Disability Rating Scale

Timeframe: Through study completion: At hospital discharge (estimated approximately 1 month from brain injury), 3 months after hospital discharge, and 6 months after hospital discharge

Trial details

NCT IDNCT07074678

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-08

View on ClinicalTrials.gov More Disorder of Consciousness trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Detection of technologic covert consciousness

Timeframe: Baseline, during hospitalization (estimated approximately 1 month from brain injury)

Functional network connectivity

Timeframe: Baseline, during hospitalization (estimated approximately 1 month from brain injury)

Detection of behavioral covert consciousness

Timeframe: Baseline, during hospitalization (estimated approximately 1 month from brain injury), within 24 hours of the functional MRI

Overt consciousness recovery based on Disability Rating Scale

Timeframe: Through study completion: At hospital discharge (estimated approximately 1 month from brain injury), 3 months after hospital discharge, and 6 months after hospital discharge