Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury
NCT Number: NCT06480838
Acronym: CAPCOG-TBI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Traumatic Brain Injury With Loss of Consciousness|Brain Injury Traumatic Severe|Brain Injury Traumatic Moderate|TBI (Traumatic Brain Injury)|TBI
Sponsor: University of Texas Southwestern Medical Center
Collaborators: Albert Einstein College of Medicine|Texas Health Resources|Institute for Exercise and Environmental Medicine|National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2028-05-31
Locations: 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

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.

Primary Outcome Measures: 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)., September 1, 2023 - May 31, 2028
Secondary Outcome Measures: 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., September 1, 2023 - May 31, 2028|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., September 1, 2023 - May 31, 2028|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., September 1, 2023 - May 31, 2028|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., September 1, 2023 - May 31, 2028|Expanded Disability Rating Scale Post-Acute Interview (E-DRS-PI), The E-DRS-PI measures the degree of disability experienced by an individual with a history of TBI using a structured interview. The answers to the interview questions are designed to guide the ratings of the items represented on the E-DRS-PI. The higher the total score, the greater the degree of disability. The interview is comprised of a series of multiple-choice questions that pertain to neurologic function, self-care and vocational activities. Depending on the answers to earlier questions relevant to a particular item, later questions are skipped. The total score will be added on the paper form. This form and the total will be uploaded into the database., September 1, 2023 - May 31, 2028|Pittsburgh Sleep Quality Index (PSQI), The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score., September 1, 2023 - May 31, 2028|NINDS Epilepsy Screening Questionnaire, NINDS-ESQ was first used and validated in the TRACK-TBI cohort as an Epilepsy screening tool. The questionnaire consisted of screening items in which the participant has to answer if they had experienced (or were told they experienced) any of the following: item 1a, "Uncontrolled movements of part or all of your body such as twitching, jerking, shaking, or going limp, lasting about 5 minutes or less?"; item 1b, "An unexplained change in mental state or level of awareness; or an episode of "spacing out" which you could not control, lasting about 5 minutes or less?"; and item 1c, "Any other type of repeated unusual attacks or convulsions lasting about 5 minutes or less?" In addition, the patient was asked item 1d, "Has anyone ever told you that you have seizure(s) or epilepsy?", September 1, 2023 - May 31, 2028|Rivermead Post-concussion Questionnaire (RPQ), The Rivermead PCS Questionnaire (RPQ) was originally developed as a measure of severity of symptoms following MTBI. It consists of 16 post-concussion symptoms including headaches, dizziness, nausea/vomiting, noise sensitivity, sleep disturbance, fatigue, irritability, feeling depressed/tearful, feeling frustrated/ impatient, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision and restlessness. In the original version of the RPQ, participants are asked to rate the degree (on a scale of 0 to 4) to which a particular symptom has been absent or a mild, moderate or severe problem over the previous 24 hours compared with premorbid levels. Note that the five-point rating scale asks the respondent to compare his/her current symptoms (if any) to symptoms experienced prior to the current injury. Thus, a score of 0 (i.e., "not experienced) means the symptom was not previously experienced and is currently not a problem., September 1, 2023 - May 31, 2028|Participant Health Questionnaire (PHQ)-9, The Participant Health Questionnaire 9 is a standardized assessment instrument designed to screen, diagnose, monitor, and measure the severity of depression., September 1, 2023 - May 31, 2028|Columbia Suicide Severity Rating Scale (C-SSRS), The Columbia Suicide Severity Rating Scale is a standardized assessment instrument designed to assess the presence and severity of suicidal ideation and behavior, identify those at risk and track response to treatment. Four constructs are measured. The first is the severity of ideation (hereafter referred to as the "severity subscale"), which is rated on a 5-point ordinal scale. The second is the intensity of ideation subscale (hereafter referred to as the "intensity subscale"), which comprises 5 items, each rated on a 5-point ordinal scale. The third is the behavior subscale, which is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. And the fourth is the lethality subscale, which assesses actual attempts., September 1, 2023 - May 31, 2028