NCT05725993

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Feb 2022Mar 2027

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.1 years

First QC Date

February 2, 2023

Last Update Submit

March 30, 2026

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Brain Atrophy

    Rate of brain tissue volume loss quantified from serial brain MRI examinations

    3 years

Study Arms (2)

TBI Patient

Healthy Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Age 18-65, inclusive
  • History of non-penetrating TBI of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (CT) scan.
  • High-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.)
  • Immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded)

You may not qualify if:

  • 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)
  • History of premorbid disability condition that would interfere with outcome assessments
  • Bilaterally absent pupillary Reponses
  • Penetrating TBI
  • 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)
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19041, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

February 1, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

US(1)