Recruiting

Neurocognitive Outcomes

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06480838

Conditions

Traumatic Brain Injury With Loss of Consciousness

Brain Injury Traumatic Severe

Brain Injury Traumatic Moderate

TBI (Traumatic Brain Injury)

TBI

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Traumatic Brain Injury With Loss of Consciousness

Brain Injury Traumatic Severe

Brain Injury Traumatic Moderate

TBI (Traumatic Brain Injury)

TBI

Study ID

NCT06480838

Start date

Sep 1, 2023

Status verified date

Jun, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kan Ding, MD

214-648-3571kan.ding@utsouthwestern.edu

Jill Morales, MS

214-648-3571Epitbiresearch@utsouthwestern.edu

Locations

Texas Health Presbyterian Hospital

Recruiting

Dallas, Texas, United States, 75231

Contacts

Philip Edmundson, MD

philipedmundson@texashealth.org

Jill Morales, BA

jill.morales@utsouthwestern.edu

Principal Investigator:

Kan Ding, MD

Parkland Health and Hospital System

Recruiting

Dallas, Texas, United States, 75235

Contacts

Alex Valadka, MD

alex.valadka@utsouthwestern.edu

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Kan Ding, MD

kan.ding@utsouthwestern.edu

Jill Morales, BA

jill.morales@utsouthwestern.edu

Principal Investigator:

Kan Ding, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-02.