Longitudinal Assessment of Traumatic Microvascular Injury-2

Last updated: March 30, 2026
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Traumatic Brain Injury

Neurologic Disorders

Memory Loss

Treatment

N/A

Clinical Study ID

NCT05725993
852096
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-65, inclusive

  2. History of non-penetrating TBI of at least moderate severity (defined by evidence oftrauma-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 toexpanding lesions will be excluded)

Exclusion

Exclusion Criteria:

  1. History of premorbid disabling neurological or psychiatric disease (such asepilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses,vascular malformations, cerebrovascular disease, Alzheimer's disease, multiplesclerosis, HIV-encephalitis)

  2. History of premorbid disability condition that would interfere with outcomeassessments

  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, renalimpairment [GFR < 60ml/g/m3], claustrophobia, hemodynamic instability)

  6. 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

Study Design

Total Participants: 110
Study Start date:
February 01, 2022
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19041
    United States

    Active - Recruiting

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