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

NCT03191357 | Completed

• 1 other identifier: MED-83-2622
• Study Type: observational
• Target: 424
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

traumatic brain injury,posttraumatic stress,service member

Outcome Measures

Primary Outcomes (1)

• Broad-spectrum military subject recruitment database

  Capture data for up to 2000 male and female service members, as well as others who are also eligible for care in the DoD healthcare system, with signs and symptoms of TBI , PCS, PTS or PTSD and/or other PH concerns, or relevant controls. Assessments and procedures include self-report questionnaires, brief physical exam, neuroimaging, neurocognitive assessment, and blood sample collection. Data collected will be stored and managed by the CNRM data repositories.

  five years

Secondary Outcomes (3)

• Improvement of recruitment methods

  five years

• Enrollment and referral

  five years

• Recruitment databases

  five years

Study Arms (4)

TBI/no PH

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) without psychological health (PH) concerns. no intervention/Observational

Other: n/a observational

TBI with PH

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) and also have psychological health (PH) concerns. no intervention/Observational

Other: n/a observational

PH only

Active and reserve component SMs along with others who are eligible for care in the DoD healthcare system, who have experience psychological health (PH) concerns. no intervention/Observational

Other: n/a observational

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). no intervention/Observational

Other: n/a observational

Interventions

n/a observational OTHER

Observational study

Controls; PH only; TBI with PH; TBI/no PH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participant population for the study includes all active duty, retired military SMs, TRICARE eligible reservists or National Guard, or interested family members who are at least 18 years and eligible for care in the DoD healthcare system; participants may be of any racial or ethnic origin, gender, or sexual orientation.

You may qualify if:

• Male or female, at least 18 years of age.
• Active duty, retired military SM, TRICARE eligible reservist or National Guardsman, or a family member eligible for care in the DoD healthcare system.
• Ability to provide self-consent
• For TBI participants, must report having symptoms or diagnosis of a concussion, TBI with or without loss of consciousness, or PCS; the duration of time since the head injury will be documented, but there is no limitation on duration since some CNRM studies do not place a time limit. Medical documentation is preferred but not required
• For participants with psychological health concerns, must report having current symptoms or may already have a diagnosis of PTSD, depression, or generalized anxiety disorder.
• For injured participants without TBI, must be (i) exposed to primary blast or (ii) have other orthopedic and/or soft-tissue injury for which they sought care at a medical treatment facility within the past six months. Injury sustained can be combat or non-combat related.
• For healthy controls, must be healthy with no prior diagnosis of TBI, concussion, PTSD, and/or other PH issues, and no history of exposure to blast.
• Are willing to have their contact information and data shared and stored by the CNRM for referral to current and future CNRM studies.

You may not qualify if:

• Individuals who are unable to provide their own informed consent for the study
• Individuals who are unwilling or unable to cooperate with study procedures
• Individuals with penetrating brain injury with residual shrapnel or other MRI-incompatible metal embedded in the brain or skull (excluded from MRI only, can still take part in study)
• Individuals with contraindication to MRI scanning including certain metal implants or devices (excluded from MRI only, can still take part in study)
• Those with conditions precluding entry or prolonged durations in the MRI scanners, e.g. morbid obesity, severe claustrophobia, etc., (excluded from MRI only, can still take part in study)
• Pregnancy: urine pregnancy tests will be performed on all females prior to the conduct of MRI; if a positive pregnancy test is identified, MRI will not be performed, can still take part in study.
• Individuals with self reported psychosis, schizophrenia, schizoaffective disorder, bipolar disorder, conversion disorder or personality disorder.

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

Uniformed Services University of Health Sciences (USUHS)

Bethesda, Maryland, 20814, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

During this study, no more than 40 mL or one ounce, of blood will be drawn. Participants may decline the blood draw and still participate in other study procedures. A phlebotomist, research nurse, or trained and credentialed study team member will draw samples. The samples sent directly to the CNRM Biospecimen Repository. WRNMMC samples will be transported by Runners Courier services. The FBCH samples will be packaged and shipped overnight FedEx directly to the Biospecimen Repository.

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 Officials

• Michael J Roy, MD, MPH

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 19, 2017
• Study Start: March 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 17, 2020

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)