Traumatic Brain InjuryNCT05917665
Early Digital, Analyte and Neurologic Biomarkers of Acute and Chronic Brain Injury and Recovery in CQT Instructors
An observational study of Traumatic Brain Injury, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Inclusion in the study is limited to 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.
Who cannot join
- Must be 18 yo or older
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Repetitive blast exposure has been shown to lead to more severe neurobehavioral impairments versus a single exposure (e.g., Gao, et al, 2017). As a result, it is important to monitor service members that are exposed to multiple blast-generated mTBIs in order to allow the earliest identification of acute or chronic brain and body insult and provide individualized measures of time to recovery. Although time to recovery and return to work decisions are critical to unit readiness, currently the prediction of outcome after mTBI is difficult, whether the outcome is measured by the time to recovery, the persistence of symptoms, or the development of a post-concussion syndrome (PCS).
Blast-induced TBI can lead to short- and long-term adverse outcomes. Many with TBI experience severe symptoms immediately following the physical trauma, with 26.1% reporting loss of consciousness and 22.4% losing memory of events before or after the injury . However, symptoms are varied (i.e. difficulty concentrating, compromised executive function, headache, confusion, amnesia, chronic pain, mental health conditions, etc.) and can present months or years after the injury, with as many as 53% of those who suffer from TBI experiencing symptoms a year or more post-injury). Long-term effects are serious and even increase the risk of chronic decline, such as dementia and Parkinson's Disease. 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 hope to learn whether daily continuous and long-term information about the physical and mental status of warfighters that is collected by wearable sensors and a mobile app can accurately monitor and predict physical and mental performance, as well as to increase warfighter self-knowledge and personal awareness on the best methods to monitor and maximize physical and mental performance. This research is being funded by the Defense Health Agency through the Congressionally Directed Medical Research Programs (CDMRP).
Participants will participate in the study for 9 weeks to 18 months during classes which they instruct. They will be asked to complete baseline surveys on the app related to demographics, personality, psychology, lifestyle, and brain function. The research mobile app is the main hub of the study and will collect data from wearable sensors (i.e. the Apple Watch) in the research study, as well as have surveys to fill out and other resources such as information on nutrition, sleep, and meditation. They may also be asked to complete daily and weekly surveys during the study. At the end of the study, they will be given additional end-of-study surveys via the mobile app, which may include surveys about experience with the wearable sensors and the mobile app, as well as other follow-up surveys.
Wearables: The Apple Watch will collect activity data including heart rate, daily steps total, estimated energy expenditure, distance moved, minutes of activity, and sleep, synched with the research mobile app and stored in a database for research analysis by the research team
Participants will be offered the continuous glucose monitor (CGM) which will collect data on glucose levels.
Blood will be drawn to test for blood biomarkers (UCH-L1 and GFAP) of blast exposure 2 times per week during most of the 9-week duration of a training class. The only exception will be during week 5 of the class, where the preponderance of blast overpressure is experienced by the cadre during breaching training. During week 5, blood will be drawn 2 times per day.
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, mTBI, concussion, glucose intolerance, blood biomarkers, blast overpressure
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Glucose Intolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Aug 2025
- Primary completion27 Feb 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Saxon, MD, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917665
- Sponsor's protocol ID
- Brain Health CQT
- Status last verified
- Aug 2026
- First submitted
- 10 May 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Digital, Analyte and Neurologic Biomarkers of Acute and Chronic Brain Injury and Recovery in CQT Instructors
- ClinicalTrials.gov ID
- NCT05917665
- Acronym / sponsor ID
- Brain Health CQT
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, mTBI, concussion, glucose intolerance, blood biomarkers, blast overpressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Repetitive blast exposure has been shown to lead to more severe neurobehavioral impairments versus a single exposure (e.g., Gao, et al, 2017). As a result, it is important to monitor service members that are exposed to multiple blast-generated mTBIs in order to allow the earliest identification of acute or chronic brain and body insult and provide individualized measures of time to recovery. Although time to recovery and return to work decisions are critical to unit readiness, currently the prediction of outcome after mTBI is difficult, whether the outcome is measured by the time to recovery, the persistence of symptoms, or the development of a post-concussion syndrome (PCS).
Blast-induced TBI can lead to short- and long-term adverse outcomes. Many with TBI experience severe symptoms immediately following the physical trauma, with 26.1% reporting loss of consciousness and 22.4% losing memory of events before or after the injury . However, symptoms are varied (i.e. difficulty concentrating, compromised executive function, headache, confusion, amnesia, chronic pain, mental health conditions, etc.) and can present months or years after the injury, with as many as 53% of those who suffer from TBI experiencing symptoms a year or more post-injury). Long-term effects are serious and even increase the risk of chronic decline, such as dementia and Parkinson's Disease. 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 hope to learn whether daily continuous and long-term information about the physical and mental status of warfighters that is collected by wearable sensors and a mobile app can accurately monitor and predict physical and mental performance, as well as to increase warfighter self-knowledge and personal awareness on the best methods to monitor and maximize physical and mental performance. This research is being funded by the Defense Health Agency through the Congressionally Directed Medical Research Programs (CDMRP).
Participants will participate in the study for 9 weeks to 18 months during classes which they instruct. They will be asked to complete baseline surveys on the app related to demographics, personality, psychology, lifestyle, and brain function. The research mobile app is the main hub of the study and will collect data from wearable sensors (i.e. the Apple Watch) in the research study, as well as have surveys to fill out and other resources such as information on nutrition, sleep, and meditation. They may also be asked to complete daily and weekly surveys during the study. At the end of the study, they will be given additional end-of-study surveys via the mobile app, which may include surveys about experience with the wearable sensors and the mobile app, as well as other follow-up surveys.
Wearables: The Apple Watch will collect activity data including heart rate, daily steps total, estimated energy expenditure, distance moved, minutes of activity, and sleep, synched with the research mobile app and stored in a database for research analysis by the research team
Participants will be offered the continuous glucose monitor (CGM) which will collect data on glucose levels.
Blood will be drawn to test for blood biomarkers (UCH-L1 and GFAP) of blast exposure 2 times per week during most of the 9-week duration of a training class. The only exception will be during week 5 of the class, where the preponderance of blast overpressure is experienced by the cadre during breaching training. During week 5, blood will be drawn 2 times per day.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Inclusion in the study is limited to 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.
Key exclusion criteria (1 listed)
- Must be 18 yo or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Biomarkers and blast exposure
Time frame: 18 months
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.
Blood Biomarkers and neurophysiologic metrics
Time frame: 18 months
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.
Blood Biomarkers and psychologic metrics
Time frame: 18 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Biomarkers and blast exposure (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.