Understanding brain function and cognitive outcomes after traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the relationship between cerebrovascular injury and cognitive outcomes in individuals who have experienced moderate to severe traumatic brain injury (msTBI). By measuring cerebral autoregulation and brain perfusion within the first year post-injury, the study seeks to determine how these factors influence cognitive recovery at 12 months. The findings will enhance our understanding of the vascular mechanisms contributing to cognitive decline and may inform future strategies to improve cognitive outcomes and prevent neurodegeneration in msTBI survivors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented/Verified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV pedestrian/cyclist, fall, other non-intentional, violence/assault)
* A documented moderate to severe TBI defined as: Glasgow Coma Scale (GCS) \< 13, or loss of consciousness (LOC) \> 30 minutes, or posttraumatic amnesia (PTA) \> 24 hours or intracranial neuroimaging abnormalities
* Between the age 18 - 80 year-old
* ≤ 1 week postinjury
* Acute brain CT for clinical care
* Admitted to the hospital for TBI
* Visual acuity/hearing adequate for testing
* Fluent in English or Spanish
* Patient or LAR ability to provide informed consent

Exclusion Criteria:

* Age greater or less than the range 18-80 years
* Significant polytrauma that would interfere with follow-up and outcome assessment
* Major debilitating baseline mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression with active suicidal thoughts at the time of evaluation) that would interfere with follow-up and the validity of outcome assessment.
* Major debilitating neurological disease (e.g., stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.
* Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g., active substance abuse, alcoholism, HIV/AIDs, end-stage cancers, learning disabilities, developmental disorders)
* Patients on psychiatric hold
* Prisoners or patients in custody
* Pregnancy in female subjects
* Low likelihood of follow-up (e.g., participants or family indicating low interest, residence in another state or country, homeless or lack of reliable contacts)
* Current participant in an interventional trial (e.g., drug, device, behavioral)
* Penetrating TBI
* Spinal cord injury with ASIA score of C or worse
* Contraindications to MRI

Where it's running

• Texas Health Presbyterian Hospital
  Dallas, Texas, United States Recruiting
• Parkland Health and Hospital System
  Dallas, Texas, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Kan Ding, MD — University of Texas Southwestern Medical Center
• Study coordinator: Kan Ding, MD
• Email: kan.ding@utsouthwestern.edu
• Phone: 214-648-3571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.