Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06480838

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

61 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

This research aims to understand how early brain blood flow problems after moderate to severe traumatic brain injury (msTBI) affect thinking skills and brain health one year later. The study focuses on how damage and recovery of blood flow regulation in the brain relate to cognitive outcomes and brain changes after injury. Researchers hope to learn how these blood flow issues contribute to cognitive decline and dementia risk in people with msTBI, helping to develop new ways to protect brain function. Participants include 100 adults with moderate to severe TBI and 30 control subjects with orthopedic injuries. Brain blood flow and oxygen levels will be measured using non-invasive methods like ultrasound, Doppler, near-infrared light, and blood pressure monitoring. These assessments will occur soon after injury (within one week) and again at 3, 6, and 12 months. Brain scans using MRI will also be done at 3 and 12 months to assess brain volume and nerve fiber health. During the study, participants will undergo cognitive tests, questionnaires about quality of life, and functional outcome assessments over the course of 12 months. The main outcome is cognitive performance measured by the NIH Toolbox Cognitive Battery at 12 months. Secondary measures include memory tests, processing speed, functional outcome scales, and assessments of sleep and mood. The study will track brain blood flow changes, cognitive recovery, and brain imaging biomarkers to better understand long-term effects of msTBI.

CONDITIONS

Brief 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) meeting ACRM criteria
  • Glasgow Coma Scale less than 13, or loss of consciousness over 30 minutes, or posttraumatic amnesia over 24 hours, or neuroimaging abnormalities
  • Age between 18 and 80 years
  • Within 1 week of injury
  • Acute brain CT scan for clinical care
  • Hospital admission for TBI
  • Adequate vision and hearing for testing
  • Fluent in English or Spanish
  • Ability to provide informed consent by patient or legally authorized representative
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 80 years
  • Significant multiple injuries that interfere with follow-up
  • Major mental health disorders like schizophrenia, bipolar disorder, or severe depression with suicidal thoughts
  • Major neurological diseases such as stroke, dementia, or brain tumor
  • Pre-existing conditions interfering with follow-up (e.g., substance abuse, end-stage cancer, developmental disorders)
  • Patients on psychiatric hold
  • Prisoners or those in custody
  • Pregnancy
  • Low likelihood of follow-up (e.g., homeless, no reliable contacts)
  • Current participation in other interventional trials
  • Penetrating traumatic brain injury
  • Spinal cord injury with severe impairment (ASIA score C or worse)
  • Contraindications to MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Less than 1 week postinjury

Participants undergo assessments of cerebral autoregulation, brain perfusion, and cognitive function within the first week after injury.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are followed longitudinally with repeated assessments of cerebrovascular function, cognitive outcomes, and brain imaging to evaluate recovery and neurodegeneration.

Visits at 3, 6, and 12 months postinjury

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

J

Jill Morales, MS

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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Published Research Related To This Trial

Association of Severe Traumatic Brain Injury Patient Outcomes With Duration of Cerebrovascular Autoregulation Impairment Events.

Aidanas Preiksaitis, Solventa Krakauskaite, Vytautas Petkus...

https://pubmed.ncbi.nlm.nih.gov/26695090

Impaired cerebral autoregulation and 6-month outcome in children with severe traumatic brain injury: preliminary findings.

M S Vavilala, S Muangman, Nuj Tontisirin...

https://pubmed.ncbi.nlm.nih.gov/16943658