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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06480838
Status
Recruiting
Apply to this trial

Conditions

  • Brain Injury Traumatic Moderate
  • Brain Injury Traumatic Severe
  • TBI
  • TBI (Traumatic Brain Injury)
  • Traumatic Brain Injury With Loss of Consciousness

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Jun 2025
Primary completion
Mar 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: msTBI
    Subjects with moderate to severe TBI within the first week after initial injury
  • Arm: Orthopedic control
    Orthopedic trauma controls within the first week after initial injury

Primary Outcome Measure

NIH Toolbox Cognitive Battery [ Time Frame: September 1, 2023 - May 31, 2028 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Parkland Health and Hospital SystemDallasTexas75235
Alex Valadka, MD
[email protected]
Alex Valadka (SUB_INVESTIGATOR)
Texas Health Presbyterian HospitalDallasTexas75231
Philip Edmundson, MD
[email protected]
Jill Morales, BA
[email protected]
Kan Ding, MD (PRINCIPAL_INVESTIGATOR)
Philip Edmundson, MD (SUB_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Kan Ding, MD
[email protected]
Jill Morales, BA
[email protected]
Kan Ding, MD (PRINCIPAL_INVESTIGATOR)
Rong Zhang, PhD (PRINCIPAL_INVESTIGATOR)
David Zhu, PhD (PRINCIPAL_INVESTIGATOR)
C M Cullum, PhD (SUB_INVESTIGATOR)
Yulun Liu, PhD (SUB_INVESTIGATOR)

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By research site
Parkland Health and Hospital System· Dallas, TXTexas Health Presbyterian Hospital· Dallas, TXUT Southwestern Medical Center· Dallas, TX

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