About this trial
Cognitive impairment after moderate to severe traumatic brain injury (msTBI) not only significantly affects the quality of life in individuals with msTBI, but also increases the possibility of late-life dementia. The goal of this study is to determine whether acute (\< 1 week) cerebrovascular injury and its recovery within the first year postinjury measured by cerebral autoregulation and brain perfusion are associated with cognitive outcome at 12 months after msTBI. The results from this study will improve our understanding of cerebrovascular contributions to cognitive decline related to TBI and provide critical data to inform the development of strategies based on vascular mechanisms to improve cognition and prevent neurodegeneration after msTBI.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
Albert Einstein College of Medicine
Collaborator
Texas Health Resources
Collaborator
Institute for Exercise and Environmental Medicine
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator