💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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