Longitudinal Assessment of Traumatic Microvascular Injury-2

Traumatic Brain Injury Clinical Trial

— LATMI-2  

Official title:

Longitudinal Assessment of Traumatic Microvascular Injury-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725993
• Other study ID #: 852096
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Atrophy	Rate of brain tissue volume loss quantified from serial brain MRI examinations	3 years