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Evaluation of Military Service and Family Members for Post Concussive and Posttraumatic Stress Symptoms

NCT03191357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 424

Last updated 2020-11-17

No results posted yet for this study

Summary

This protocol is designed to facilitate the recruitment, screening and registry of Military Service Members (SMs) and individuals eligible for care in the Department of Defense (DoD) healthcare system. This protocol will serve as an entry point for SMs, retirees and other beneficiaries, to facilitate their participation in Center for Neuroscience and Regenerative Medicine (CNRM)-sponsored clinical research studies at participating CNRM sites. Specifically, this protocol will be comprised of an initial evaluation of participants, to include questionnaires, a blood draw, and neuroimaging. This evaluation will enable investigators to direct participants to CNRM-sponsored natural history, observational, or interventional protocols that are most relevant to the individual interests and needs of each participant. Other approved CNRM protocols may continue to recruit participants directly into their respective studies, and may refer participants to this study.

The objective of this protocol is to develop a broad-spectrum military subject recruitment database that will collect and store preliminary data on research participants who are interested in and potentially eligible for current and future CNRM sponsored studies. The effectiveness of the recruitment methods utilized in this protocol will be evaluated to determine the most successful outreach approaches and recruitment tools for the enrollment of participants, including both active and reserve component SMs along with others who are eligible for care in the DoD healthcare system, who have experienced traumatic brain injury (TBI), psychological health (PH) concerns, or are interested in participating in studies as controls. Control participants may include (i) those with exposure to primary blast without the development of TBI, (ii) those with physical injuries without experiencing head injury, and (iii) healthy participants (non-injured, non-TBI, non-PH).

Conditions

  • TBI (Traumatic Brain Injury)

Interventions

OTHER

n/a observational

Observational study

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • Uniformed Services University of the Health Sciences

    lead FED

Principal Investigators

  • Michael J Roy, MD, MPH · Uniformed Services University of the Health Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03191357 on ClinicalTrials.gov