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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Texas Southwestern Medical Center

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

130 Participants
are grouped into 2 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