Early Digital, Analyte and Neurologic Biomarkers of Acute and Chronic Brain Injury and Recovery in CQT Instructors

NCT05917665 | Enrolling By Invitation

• 1 other identifier: Brain Health CQT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive blast exposure has been shown to lead to more severe neurobehavioral impairments versus a single exposure. Blast-induced Traumatic Brain Injury (TBI) can lead to short- and long-term adverse outcomes Even mild brain injuries can impair neurocognitive performance, and repeated injuries can amplify negative outcomes. Service members with repeated exposure to low-level blasts as a necessary part of their job or training display altered neural activity during a memory task that is paralleled by a reduction in accuracy on neurocognitive memory tasks. As a result, it is important to monitor service members that are exposed to multiple blast-generated mTBIs to allow the earliest identification of acute or chronic brain and body insult and provide individualized measures of time to recovery. While TBI is clinically diagnosable, the methods of diagnosis have up to now been typically expensive and immobile, and treatments and interventions sparse. The investigators will conduct a longitudinal assessment of mTBI brain biomarkers by collecting repeated measures of FDA approved mTBI brain injury biomarkers, correlated with sound and blast exposure, as well as continuous monitoring through smart watches (activity, sleep, biometrics, calorie expenditure, balance) and analyte data through analyte sensors (glucose, lactate, ketones). Study data will be organized into categories and presented to participants daily within the application and will be securely stored within the application. At the completion of the study, participants will be provided with the study data digitally within the mobile application and study data will also be provided to the credentialed unit medical provider to enable it to be ported to the participants' electronic medical record. This study will create a continuous record of blast overpressure and sound exposures and correlate those to the participants health state over the course of several 9-week courses. This will enable an assessment of individualized susceptibility to brain injury as well as providing novel data on time to recovery. The investigators hope to develop dynamic and accurate risk profiles that are individual and will lead to further understanding of how to protect participants from mTBI (mild TBI) events.

Conditions

Traumatic Brain Injury

Keywords

TBI; mTBI; concussion; glucose intolerance; blood biomarkers; blast overpressure

Outcome Measures

Primary Outcomes (3)

• Blood Biomarkers and blast exposure

  Determine if repeated measures of FDA approved mTBI brain injury biomarkers (for concussive injury) are correlated with sound and blast exposure. Measures of blood biomarkers, ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), will be taken to determine if they are elevated after acute or chronic blast exposure as measured with dosimeters and blast gauges.

  18 months

• Blood Biomarkers and neurophysiologic metrics

  Determine if repeated measures of FDA approved mTBI brain injury biomarkers (for concussive injury) are correlated with neurophysiologic metrics. Measures of blood biomarkers, ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), will be taken to determine if they are elevated in correlation with neurophysiologic metrics such as heart rate, HRV, respiration, sleep and activity.

  18 months

• Blood Biomarkers and psychologic metrics

  Determine if repeated measures of FDA approved mTBI brain injury biomarkers (for concussive injury) are correlated with psychologic metrics. Measures of blood biomarkers, ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), will be taken to determine if they are elevated in correlation with psychologic measures such as depression, PTSD, cognitive changes, and post-concussive symptoms.

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Instructors of the Special Forces Advanced Reconnaissance Target Analysis and Exploitation Techniques Course (SFARTAETC) at Range 37, D Co. 2nd BN / 2nd SWTG(A) at Fort Bragg, NC. All participants will be employees of the Army, but they will range from Active Duty Service Members to civilian Governments employees to Contractors. All will be instructing soldiers in the SFARTAETC training course. All SFARTAETC instructors will be invited to participate.

You may not qualify if:

• Must be 18 yo or older

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Ft. Bragg

Fort Bragg, North Carolina, 28307, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma to identify blood biomarkers for blast exposure

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Glucose Intolerance

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Executive Director, USC Center for Body Computing,

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 26, 2023
• Study Start: February 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

US (1)