Brain injury study aims to sharpen diagnosis with MRI

NCT ID NCT01132937

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 15 times

Summary

This study looked at 886 adults with suspected traumatic brain injury to better understand how the brain changes after injury. Participants had MRI scans, blood tests, and thinking tests within 48 hours of injury, with optional follow-ups up to a year. The goal was to find better ways to diagnose and classify brain injuries, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better diagnose and classify traumatic brain injuries early on, leading to more consistent care.
What could go wrong
This is an observational study, not a treatment trial. It may not directly improve outcomes or lead to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

886 people

The number who actually took part.

Started

Oct 2010

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Enrollment in this protocol will occur at a participating site MedStar Washington Hospital Center (WHC) or Johns Hopkins Suburban Hospital (Suburban). Applicable study procedures will depend on the visit site, diagnostic certainty, and logistic considerations such as ability to be moved to MR suite for imagining in local hospital. All subjects will undergo a study visit at a participating enrollment site with in 48hrs of suspected head injury.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Suspected TBI Subjects Suspected TBI subjects must meet the following inclusion criteria: 1. History of acute head injury with or suspected non-penetrating acute TBI 2. Age 18 years or older 3. Deemed medically safe for study participation by the subject s attending physician 4. Able to provide consent or have a legally-authorized representative provide consent. Healthy Volunteers Healthy volunteers must meet the following inclusion criteria: 1. Healthy without past or present history of TBI or other brain disease, as evaluated by medical history and physical exam 2. Age 18 or older. 3. Able to provide informed consent EXCLUSION CRITERIA: Suspected TBI Subjects Suspected TBI subjects are not eligible for participation in this research study if any of the following conditions exist: 1. Considered to be psychiatrically unstable by the patient s attending physician 2. Contraindication to MRI scanning including: pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments. 3. Conditions precluding entry into the scanner such as morbid obesity or claustrophobia or conditions requiring sedation. 4. In female subjects, pregnancy. Healthy Volunteers Healthy volunteers are not eligible for participation in this research study if any of the following conditions exist: 1. Presence of cognitive impairment based on medical history and/or Mini Mental State Examination (MMSE) score of \< 27 2. Current or past DSM-IV diagnosis of a psychiatric disorder including substance use disorder as determined by self-report, medical history, and/or clinical exam 3. Major medical problems that can impact brain function (e.g., problems of the CNS including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam; 4. Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a subject s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the subject s eyes). 5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.). 6. In female subjects, pregnancy or breastfeeding. 7. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits. Currently Phase-1 of enrollment for healthy volunteers in the A Beta PET pilot is complete. At this time enrollment of healthy volunteers is on hold until analysis complete. Enrollment of A Beta PET pilot TBI subjects and healthy matches may resume under Phase-2 if analysis of initial data suggests update

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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