Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05917665 |
| Other study ID # |
Brain Health CQT |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
October 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Southern California |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
