RECRUITING

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

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Conditions

Traumatic Brain Injury With Loss of ConsciousnessBrain Injury Traumatic SevereBrain Injury Traumatic ModerateTBI (Traumatic Brain Injury)TBI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-01
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06480838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented/Verified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV pedestrian/cyclist, fall, other non-intentional, violence/assault)
  2. * 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
  3. * Between the age 18 - 80 year-old
  4. * ≤ 1 week postinjury
  5. * Acute brain CT for clinical care
  6. * Admitted to the hospital for TBI
  7. * Visual acuity/hearing adequate for testing
  8. * Fluent in English or Spanish
  9. * Patient or LAR ability to provide informed consent
  1. * Age greater or less than the range 18-80 years
  2. * Significant polytrauma that would interfere with follow-up and outcome assessment
  3. * 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.
  4. * Major debilitating neurological disease (e.g., stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.
  5. * 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)
  6. * Patients on psychiatric hold
  7. * Prisoners or patients in custody
  8. * Pregnancy in female subjects
  9. * 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)
  10. * Current participant in an interventional trial (e.g., drug, device, behavioral)
  11. * Penetrating TBI
  12. * Spinal cord injury with ASIA score of C or worse
  13. * Contraindications to MRI

Contacts and Locations

Study Contact

Kan Ding, MD
CONTACT
214-648-3571
kan.ding@utsouthwestern.edu
Jill Morales, BA
CONTACT
214-648-3571
jill.morales@utsouthwestern.edu

Principal Investigator

Kan Ding, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

Texas Health Presbyterian Hospital
Dallas, Texas, 75231
United States
Parkland Health and Hospital System
Dallas, Texas, 75235
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Kan Ding, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2028-05-31

Terms related to this study

Additional Relevant MeSH Terms

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