Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how brain blood flow and brain health immediately after a moderate to severe traumatic brain injury (TBI) can affect thinking and memory skills one year later. The researchers want to understand if these early changes in the brain's blood flow can predict cognitive problems that may arise after the injury. This information could help in developing new ways to support better brain health and prevent issues like dementia in the future.

To participate in the trial, individuals aged 18 to 80 who have recently suffered a moderate to severe TBI—indicated by factors such as a low score on a common brain injury scale or prolonged loss of consciousness—may be eligible. Participants will be asked to undergo some tests and assessments related to their brain function and recovery. It’s important to note that certain conditions, such as severe mental health disorders or other significant injuries, might prevent someone from joining the study. This trial is currently recruiting participants, and those who take part will contribute valuable information that could lead to better care for individuals recovering from TBI.

Gender

ALL

Eligibility 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