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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Parkland Health and Hospital System
RECRUITING
Dallas
Texas Health Presbyterian Hospital
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Kan Ding, MD
kan.ding@utsouthwestern.edu
214-648-3571
Backup
Jill Morales, MS
Epitbiresearch@utsouthwestern.edu
214-648-3571
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 130
Treatments
msTBI
Subjects with moderate to severe TBI within the first week after initial injury
Orthopedic control
Orthopedic trauma controls within the first week after initial injury
Related Therapeutic Areas
Sponsors
Collaborators: Albert Einstein College of Medicine, Institute for Exercise and Environmental Medicine, Texas Health Resources, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov