Understanding brain function and cognitive outcomes after traumatic brain injury
Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury
This study is trying to see how blood flow and brain health after a serious head injury affect thinking and memory recovery one year later for those who have had a moderate to severe traumatic brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 3 sites (Dallas, Texas and 2 other locations) |
| Trial ID | NCT06480838 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who have sustained a documented moderate to severe traumatic brain injury within one week of injury.
Not a fit: Patients with significant polytrauma or major debilitating mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for cognitive recovery and prevention of dementia in patients with traumatic brain injury.
How similar studies have performed: Other studies have indicated a connection between cerebrovascular dysfunction and cognitive impairment in TBI, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dallas, Texas and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.