Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06480838

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

Led by University of Texas Southwestern Medical Center · Updated on 2025-07-01

130

Participants Needed

3

Research Sites

247 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

A

Albert Einstein College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented moderate to severe traumatic brain injury (TBI) according to ACRM criteria
  • Moderate to severe TBI defined by Glasgow Coma Scale less than 13, loss of consciousness over 30 minutes, posttraumatic amnesia over 24 hours, or abnormal brain imaging
  • Age between 18 and 80 years old
  • Injury occurred within 1 week prior to enrollment
  • Had an acute brain CT scan for clinical care
  • Admitted to hospital for TBI
  • Adequate vision and hearing for testing
  • Fluent in English or Spanish
  • Ability of patient or legal representative to give informed consent
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 80 years
  • Severe multiple injuries that interfere with follow-up or assessments
  • Major mental health disorders like schizophrenia, bipolar disorder, or severe depression with active suicidal thoughts
  • Major neurological diseases such as stroke, dementia, or brain tumor impairing cognition or assessment
  • Pre-existing conditions interfering with follow-up like active substance abuse, HIV/AIDS, end-stage cancers, learning disabilities, or developmental disorders
  • Patients on psychiatric hold
  • Prisoners or patients in custody
  • Pregnancy in female participants
  • Low likelihood of completing follow-up (e.g., living out of state, homeless, or lacking reliable contacts)
  • Currently enrolled in another interventional trial
  • Penetrating traumatic brain injury
  • Spinal cord injury with severe impairment (ASIA score C or worse)
  • Contraindications to MRI scanning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Texas Health Presbyterian Hospital

Dallas, Texas, United States, 75231

Actively Recruiting

2

Parkland Health and Hospital System

Dallas, Texas, United States, 75235

Actively Recruiting

3

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

K

Kan Ding, MD

CONTACT

J

Jill Morales, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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