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

NCT06070025 | Enrolling By Invitation

• 2 other identifiers: Brain Health Marine BtlnW81XWH-22-1-0956
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

brain health; traumatic brain injury; marines; wearables; physiological sensors

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

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

Healthy service members of the 1st Marine Division 1st Battalion out of Camp Pendleton, CA

You may qualify if:

• Members of the 1st Marine Division 1st Battalion

You may not qualify if:

• None

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Camp Pendleton

Oceanside, California, 92058, United States

Location

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MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: October 6, 2023
• Study Start: January 22, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)