Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05725993

Longitudinal Assessment of Traumatic Microvascular Injury-2

Led by University of Pennsylvania · Updated on 2026-03-31

110

Participants Needed

1

Research Sites

264 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to learn about changes in the brain of patients over the first 3 years following a traumatic brain injury (TBI). The main question it aims to answer are: \- How TBI effect the rate of brain tissue loss compare to healthy brain Participants will give blood samples, complete MRI scans, and neuropsychological assessment measures. Researchers will compare results between healthy control group and TBI group to determine changes in injured brains.

CONDITIONS

Official Title

Longitudinal Assessment of Traumatic Microvascular Injury-2

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65, inclusive
  • History of non-penetrating traumatic brain injury of at least moderate severity confirmed by trauma-related abnormality on CT scan
  • Injury caused by high-velocity, high-impact events such as motor vehicle accidents or falls from height
  • Immediate loss of consciousness after injury
Not Eligible

You will not qualify if you...

  • History of disabling neurological or psychiatric diseases like epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis
  • Pre-existing disability that would interfere with outcome assessments
  • No pupillary responses in both eyes
  • Penetrating traumatic brain injury
  • Elevated intracranial pressure (≥ 17 mmHg)
  • Contraindications to contrast-enhanced MRI such as ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment (GFR < 60 ml/g/m3), claustrophobia, or hemodynamic instability
  • Prisoners or patients in police custody
  • Objective lung disease with elevated PaCO2 or venous serum bicarbonate based on clinical labs
  • Requirement for portable oxygen at enrollment
  • Chronic heart failure or severe pulmonary disease
  • Current substance abuse preventing participation and follow-up
  • Any medical or other disability preventing completion of study procedures as determined by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19041

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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