Brain injury study tracks tissue loss over three years
NCT ID NCT05725993
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 110 people with moderate to severe traumatic brain injury (TBI) for up to 3 years to see how their brains change compared to healthy individuals. Participants will give blood samples, have MRI scans, and take thinking and memory tests. The goal is to measure how fast brain tissue is lost after injury, which may help improve future care.
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
-
About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2022
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
TBI subjects will be recruited directly from University of Pennsylvania Health System during their hospital stay. Healthy control subjects will be recruited via clinical practices, referring physicians, advertisements, Penn media services, social media avenues, iConnect, and community flyer.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: 1. Age 18-65, inclusive 2. History of non-penetrating TBI of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (CT) scan. 3. High-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.) 4. Immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded) Exclusion Criteria: 1. History of premorbid disabling neurological or psychiatric disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, HIV-encephalitis) 2. History of premorbid disability condition that would interfere with outcome assessments 3. Bilaterally absent pupillary Reponses 4. Penetrating TBI 5. Elevated intracranial pressure (≥ 17 mmHg) 6 Contradictions to contrast-enhanced MRI (e.g., ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment \[GFR \< 60ml/g/m3\], claustrophobia, hemodynamic instability) 7\. Prisoners, patients in police custody 8. Objective lung disease (PaCO2 at rest \> 50 mmHg or venous serum bicarbonate \> 26 mEg/L) based on any labs available for review from patient's clinical care. Note that these will not be checked solely for study purposes 9.Requiring portable oxygen at enrollment 10. Chronic heart failure, severe pulmonary disease 11. Current substance abuse that precludes participation and follow-up in the study, as determined by the study investigators 12. If there is medical or other disability that precludes completion of the study procedures as determined by the study investigators
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Traumatic brain injury are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19041, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury
- MRI tracer could expose hidden brain energy crisis after head injury