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

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ClinicalTrials.gov Identifier: NCT03191357
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Center for Neuroscience and Regenerative Medicine (CNRM)
Information provided by (Responsible Party):
Uniformed Services University of the Health Sciences

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).


Condition or disease Intervention/treatment
TBI (Traumatic Brain Injury) Other: n/a observational

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Military Service and Family Members for Post Concussive and Posttraumatic Stress Symptoms
Actual Study Start Date : March 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Observational study

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
Observational study

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
Observational study

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
Observational study




Primary Outcome Measures :
  1. Broad-spectrum military subject recruitment database [ Time Frame: five years ]
    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.


Secondary Outcome Measures :
  1. Improvement of recruitment methods [ Time Frame: five years ]
    *Use enrollment data including neuroimaging, biospecimen, neurocognitive and self-reports coupled with retention and attrition data collected through this protocol to improve recruitment methods.

  2. Enrollment and referral [ Time Frame: five years ]
    *Coordinate the enrollment of participants in CNRM studies with the greatest relevance and interest to them, maintain longitudinal contact, and offer those who are interested the opportunity to participate in subsequent CNRM studies after enrollment in this study

  3. Recruitment databases [ Time Frame: five years ]
    *Use data collected through the neurocognitive assessment (NIH Toolbox) to better direct referral to appropriate CNRM studies


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  1. Male or female, at least 18 years of age.
  2. Active duty, retired military SM, TRICARE eligible reservist or National Guardsman, or a family member eligible for care in the DoD healthcare system.
  3. Ability to provide self-consent
  4. 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
  5. For participants with psychological health concerns, must report having current symptoms or may already have a diagnosis of PTSD, depression, or generalized anxiety disorder.
  6. 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.
  7. 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.
  8. Are willing to have their contact information and data shared and stored by the CNRM for referral to current and future CNRM studies.

Exclusion Criteria:

  1. Individuals who are unable to provide their own informed consent for the study
  2. Individuals who are unwilling or unable to cooperate with study procedures
  3. 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)
  4. Individuals with contraindication to MRI scanning including certain metal implants or devices (excluded from MRI only, can still take part in study)
  5. 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)
  6. 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.
  7. Individuals with self reported psychosis, schizophrenia, schizoaffective disorder, bipolar disorder, conversion disorder or personality disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191357


Contacts
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Contact: Doren Walker, MS 855-824-2676 cnrmstudies@usuhs.edu
Contact: Patricia L Taylor, MBA, BS 240-507-6339 patricia.taylor.ctr@usuhs.edu

Locations
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United States, Maryland
Uniformed Services University of Health Sciences (USUHS) Recruiting
Bethesda, Maryland, United States, 20814
Contact: Annabel L Raboy, BS    240-234-0502    annabel.lee.raboy.ctr@usuhs.edu   
Contact: Doren Walker, MS    301-295-4389    doren.walker.ctr@usuhs.edu   
Principal Investigator: Michael J Roy, MD, MPH         
Principal Investigator: Heechin Chae, MD         
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
Investigators
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Principal Investigator: Michael J Roy, MD, MPH Uniformed Services University of the Health Sciences

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Responsible Party: Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT03191357     History of Changes
Other Study ID Numbers: MED-83-2622
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information to be shared via Fitbir

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uniformed Services University of the Health Sciences:
traumatic brain injury,posttraumatic stress,service member

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries