Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health

Traumatic Brain Injury Clinical Trial

Official title:

Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health and Adjustment Over a Marine Battalion Deployment Cycle

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06070025
• Other study ID #: Brain Health Marine Btln
• Secondary ID: W81XWH-22-1-0956
• Status: Enrolling by invitation
• Start date: January 22, 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are:

• Establish individual mental and physical performance profile and brain health baseline in Infantry Marines

• Develop predictive models to identify early signs of mental and/or physical degradation that can help predict "red-line" behavioral events and degradation in brain health.

• Gather insights that will lead to developing personalized, evidence-based interventions to restore mental and physical performance.

• Increase warfighter self-knowledge and personal awareness to monitor and maximize performance.

Participants will wear wear smart watches and analyte sensors to track their real time physiological and sleep measures and complete subjective and psychological measures in a custom research app.

Description:

To prevent brain health degradation, it is necessary to understand the factors that contribute to brain insult and injury. The investigators aim to understand and identify pre-exposure risk, reversible and irreversible injury, and the impact of stressors. The investigators will research the real-time interaction between exposure and injury biomarkers and identify how the interaction affects long-term health and measures such as time to recovery.

The project will work with a newly formed Infantry Marine Battalion on Camp Pendleton. This group of Service Members will have many that are beginning their military careers, and thus will bring in only the components of brain health and emotional trauma they have accumulated during their civilian lives to this point.

Participants will be provided with a customized research mobile application that will obtain baseline information related to their military history and experience, and then continuously track activity, physiologic parameters, sleep, cognition and emotional state. Detailed dietary consumption and metabolic data, if indicated, will be tracked and displayed. The data will be collected continuously

During the study, participants will be provided with their data in real-time and this will be displayed along with their schedule and tasks. During and upon completion of the study investigators will provide a detailed summary and analysis of their health and human performance metrics, including insights on how diet and activity impacts their metabolic control or other biomarkers and how all of these factors impact sleep, cognition and behavioral state. The investigators will collaborate with the participants to identify the most useful data displays and information that will best help them achieve optimized physical, mental and cognitive training and recovery and gain understanding of how metabolic control or other biomarkers impact these metrics.

These insights will be used to develop insight dashboards on the holistic health metrics mentioned above, and help provide optimization insights. We will work with participants to create additional app content specific for them that relates to optimal diet and mental and physical training and recovery.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Members of the 1st Marine Division 1st Battalion

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Camp Pendleton	Oceanside	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explanation of Outcomes	In a traditional clinical trial, we would have explicitly included measures, or measurement tool used to assess the measure, along with the measurement units that would be used to assess this outcome measure.; However, in this novel prospective digital health trial, these outcomes are not predefined, but are part of discovery within the digital app. Therefore these data will be reported as digital biomarkers that will not necessarily conform with the typical single or multi-variable traditional clinical trial and will include many novel measurement parameters and blended measures.; For instance, a novel measurement that will be used to assess the effect of engaging in this clinical trial will be app adherence, which is not a variable generally used in clinical trials.	18 months
Primary	Establish individual mental and physical performance profile and brain health baseline in Infantry Marines.	Establish individual mental and physical performance profile and brain health baseline in Infantry Marines from physiological and psychological assessments. Assessments will be scored and recorded to contrast with scores during the study and at its conclusion for individuals as well as the group. Scores will be used to determine correlates and other connections between variables. This will include such connections as the connection between TBI history and current cognitive and psychological assessments, etc.	1 month
Primary	Develop predictive models	Develop predictive models to identify early signs of mental and/or physical degradation that can help predict adverse brain health or behavioral events using continuous physiological data and ongoing cognitive and psychological measures. Using assessments on baseline cognitive, physiological and psychological states combined with continuous and periodic assessments of these states, changes in TBI status and cognitive status will be correlated with biomarkers such as sleep, heart rate, O2 measures, glucose measures, and others (as described elsewhere) in order to discover new indications for adverse brain health.	18 months
Primary	Increase warfighter self-knowledge and personal awareness	Determine warfighter self-knowledge and personal awareness by developing and measuring self-reported and recorded interaction with personalized educational and interventional portions of the research app. Because we are interested in individuals being invested in their own data in order to make behavioral changes, we will establish baseline assessment scores, and deliver them back to the user with explanations. Participants will also receive continuous biomarker data. This will allow participants to decide if they will make any changes in their behavior or seek help in order to improve their own health outcomes. These will be measured in the same ways as described earlier - changes in sleep patterns, changes in eating habits, changes in drinking habits, etc., as well as level of access by participants of insights and other tools in the research app.	18 months