Assessing brain changes after traumatic brain injury over three years

Longitudinal Assessment of Traumatic Microvascular Injury-2

This study looks at how brain tissue changes over three years in people who have had a traumatic brain injury compared to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Pennsylvania (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05725993 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the changes in brain tissue of patients who have experienced a traumatic brain injury (TBI) over a three-year period. Participants will undergo MRI scans, provide blood samples, and complete neuropsychological assessments. The study will compare the results of TBI patients with a healthy control group to understand the impact of TBI on brain tissue loss. The primary focus is on how TBI affects the rate of brain tissue loss compared to healthy individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who have suffered a moderate severity non-penetrating TBI with evidence of neuroimaging abnormalities.

Not a fit: Patients with pre-existing neurological or psychiatric conditions, or those who have experienced penetrating TBIs, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the long-term effects of TBI on brain health, potentially leading to improved treatment and rehabilitation strategies.

How similar studies have performed: Other studies have explored brain changes following TBI, but this specific longitudinal approach focusing on microvascular injury is relatively novel.

Eligibility criteria

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

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)

Conditions: Traumatic Brain Injury