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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Patients with either moderate to severe traumatic brain injury within one week of injury, or plain orthopedic trauma within one week of injury.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

130 Participants
are grouped into 2 trial groups
Group A: msTBI
Group B: Orthopedic control

Trial outcomes

Primary outcomes

1

NIH Toolbox Cognitive Battery

NIH Toolbox is a set of brief, comprehensive assessment tools. This study protocol will use the Cognitive battery of the Toolbox consisting of 7 subtests designed to measure executive function and attention (Flanker and Dimensional Change Card Sort), episodic memory (Picture Sequence Memory Test), working memory (List Sorting Working Memory Test), processing speed (Pattern Comparison Processing Speed and Flanker), and language (Picture Vocabulary Test). Assessments will be administered on an iPad (5th generation).

Time frame
September 1, 2023 - May 31, 2028

Secondary outcomes

1

Hopkins Verbal Learning Test-Revised (HVLT-R)

A word-list learning and episodic memory test. Each form consists of a list of 12 nouns (targets) with four words drawn from each of three semantic categories.

Time frame
September 1, 2023 - May 31, 2028
2

Trail Making Test A &B (TMT A & B)

The TMT is a measure of attention, speed, and mental flexibility. Part A requires the individual to draw lines to connect 25 encircled consecutive numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between ascending numbers and letters. Part B tests cognitive demands including visuomotor, visual scanning, and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task.

Time frame
September 1, 2023 - May 31, 2028
3

Wechsler Adult Intelligence Scale (WAIS) IV Processing Speed Index (Coding and Symbol Search subtests)

The Processing Speed Index consists of two subtests: Symbol Search and Coding.

Time frame
September 1, 2023 - May 31, 2028
4

Revised-Glasgow Outcome Scale-Extended (R-GOSE)

The Revised Glasgow Outcome Scale Extended (R-GOSE) is a measure of disability and handicap intended for use following head injury. It was developed specifically to meet the aims of the TRACK-TBI study and is based on the GOSE structured interview (Wilson et al. 1998). Unlike the GOSE, which does not distinguish between disability related to the brain injury and disability related to peripheral injuries sustained in the same incident, the R-GOSE assesses the impact of both non-CNS injuries (i.e. peripheral injuries) and the brain injury separately. As a result, two scores are obtained: an 'All' rating which reflects the participant's change in level of dependence as a function of peripheral and brain injuries combined, and a 'TBI' rating that removes the impact of the peripheral injuries leaving a disability rating that reflects only the TBI.

Time frame
September 1, 2023 - May 31, 2028

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Albert Einstein College of Medicine

Collaborator

Texas Health Resources

Collaborator

Institute for Exercise and Environmental Medicine

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator