Research and Clinical Studies

To be eligible to enroll in a study you MUST be enrolled as a DEERS-eligible service member, dependent, retiree, or DOD civilian.
 

Frequency of Oculomotor Dysfunction in Symptomatic Mild Traumatic Brain Injury (mTBI) (FOCUS mTBI) 

Purpose: Mild TBIs, also known as concussions, can affect the safety and readiness of service members and veterans. The changes in vision after a concussion can sometimes be very subtle but at the same time severely affect a person’s ability to perform vision- driven tasks. This study will determine the frequency of these vision problems after a concussion. The study will compare the frequency of these vision problems in people with a history of concussion vs. people without a history of concussion.
Eligibility Criteria: 
- The study will compare two groups, concussed and controls. For both groups, active-duty military personnel 17 (if emancipated) to 40 years old, including military academy cadets/midshipmen can participate. In addition, 
Concussed Group should have:
- Diagnosis of a concussion, 0 - 180 days post-injury AND 
- Currently experiencing persistent concussion symptoms
Control Group should have:
- No history of a concussion/whiplash in past year
- No history of vision therapy
Participant Expectations:
A comprehensive, dilated vision examination that is approximately 1-hour in length. No follow-up appointments, no treatment, all assessments are Standard of Care
Contact Information: Dr. Geeta Girdher
TBI Optometry, Bldg 51, MD 20889
Phone: 301-295-0213
IRB Number: WRNMMC-2024-0463
IRB Approval Date: 02-20-2025
Related Link(s):  Study Page

The Effects of the Menstrual and Oral Contraceptive Hormonal Cycles on Body Composition, Metabolism, and Strength

Purpose: To understand the influence of the menstrual and oral contraceptive hormonal cycles on body composition, and to determine the influence of the menstrual and oral contraceptive hormonal cycles on metabolism, isometric strength and flexibility, and perceived stress and mood states.
Eligibility Criteria: 
- Active-duty military
- Pre-menopausal female, 18-44 years old
- Not pregnant or breastfeeding
- Have a regular menstrual cycle (between 21-35 days) OR be taking an oral contraceptive
Participant Expectations:
Body composition: Inbody 770, DXA, circumference-based tape test ,Metabolism testing: indirect calorimetry
Hormone analysis: urine, saliva Hydration assessment, Strength tests: handgrip, isometric mid-thigh pull, plank
Flexibility test: sit-and-reach, Stress and mood surveys
Contact Information: Jeffery L. Heileson, 301-400-2708
Email: Jeffery.l.heileson.mil@army.mil
Tina E. Sergi, 301-400-3905
Email: tina.e.sergi.mil@health.mil
IRB Number: WRNMMC-2023-0440
IRB Approval Date: 02-15-2024

The Army Combat Fitness Test: Analyzing the Decision to Replace the Leg Tuck with the Plank

Purpose: Determine the association between the leg tuck, plank, and performance on a casualty evacuation test.
Eligibility Criteria: 
- At least 18 years old
- Not pregnant or breastfeeding
- Can complete both DXA and InBody
- Can participate in muscular performance events
Participant Expectations:
Visit 1: Body composition: DXA scan, InBody scan, circumference-based tape test) ,Hydration testing
Provide ACFT scorecard, Strength: handgrip strength, maximal effort plank
Visit 2: Casualty evacuation test, Max pull-ups and leg tucks
Contact Information: Jeffery L. Heileson, 301-400-2708
Email: Jeffery.l.heileson.mil@army.mil
Tina E. Sergi, 301-400-3905
Email: tina.e.sergi.mil@health.mil
IRB Number: WRNMMC-2023-0417
IRB Approval Date: 01-26-2025
 

Influence of the Menstrual Cycle and Hormonal Contraceptive Cycle on Nutrition and Exercise

Purpose: Describe the type, prevalence, and severity of symptoms experienced among naturally menstruating females and females using hormonal contraceptives.
Understand how female servicemembers perceive their menstrual cycle to influence training and performance.
Determine if any changes in training and nutrition are made throughout the various menstrual cycle/hormonal contraceptive cycle phases.
Eligibility Criteria: 
- Active Duty Military in the United States
- Female
- 18+ years old
Participant Expectations: Complete a 50-question online survey on Microsoft Forms.
Link to survey: https://forms.osi.apps.mil/Pages/ResponsePage.aspx?id=Q6QDiTOv1E6s9e5hO8svWQhvRe1pFzNHlTkUdxUD2VlURDFURDBSRDNTSEsyVDhTUVRGN1RLTEdEWC4u&origin=QRCode
Contact Information: Jeffery L. Heileson, 301-400-2708
Email: Jeffery.l.heileson.mil@army.mil
Tina E. Sergi, 301-400-3905
Email: tina.e.sergi.mil@health.mil
IRB Number: WRNMMC-EDO-2024-1198
IRB Approval Date: 03-04-2025
 

Evaluating Post-traumatic Stress Disorder and Traumatic Brain Injury for a Connection to Early Cardiovascular Disease

Purpose: The goal of this research is to look at the brain health and heart health of people who have experienced an mTBI and/or who have been diagnosed with PTSD. Healthy volunteers are also eligible.
Eligibility Criteria: 
- People ages 18-59, be able to have an MRI without sedation.
- Must be DEERS eligible to participate.
Participant Expectations: Following the screening, participation will involve a minimum of two study visits, which will include:  Signing the informed consent form, completing TBI and psychological assessments, wearing wrist and cardiac monitor devices, providing saliva samples and a blood draw and undergoing one MRI scan using the MAGNUS system.
Contact Information: Elyse Gollomp, Research Coordinator / Psychometrist
Email: elyse.gollomp.ctr@usuhs.edu
Haymanot Yalewayker, Program Manager
Email: haymanot.a.yalewayker.ctr@health.mil
Dr. Maureen Hood, Principal Investigator (PI)
Email: maureen.hood@usuhs.edu
IRB Number: WRNMMC-2024-0456
IRB Approval Date: 12-20-2024

Pilot Trial Comparing Exposure and Non-Exposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Purpose: The purpose of this study is to investigate two new treatments for trauma-related nightmares and to investigate biomarkers related to response to treatment.
Eligibility Criteria: 
- Active duty service members or DEERS-eligible veterans
- Ages 22-64
- Experiencing trauma-related nightmares 
Participant Expectations: Complete an at-home sleep study.
- Attend 4 in-person visits and 12 video/remote visits, at which you will complete rating forms and interviews.
- Give 5 blood samples.
- Complete a daily sleep diary.
- Wear a wristband 23 hours per day to monitor your body movement, heart rate, and stress-related physical responses of your skin.
- Be randomly assigned (50:50 chance) to receive either Nightmare Deconstruction and Reprocessing (NDR; psychotherapy) or NightWare (NW; wristband).
Contact Information: NTStudy@CSTSonline.org, or call 301-295-0625
Dr. James West (james.west@usuhs.edu, 301-319-4281
IRB Number: USUHS.2023-125
IRB Approval Date: 04-11-2024
Related Link(s):  Study Page

Comparative cohort study of post-acute Covid-19 infection with a nested, randomized controlled trial of ivabradine for those with postural orthostatic tachycardia syndrome (COVIVA) study

Purpose: The purpose of the study is three-fold. The primary aim is to identify the proportion of Long-Haul COVID (LHC) and non-LHC volunteers with relevant symptoms actually have postural orthostatic tachycardia syndrome (POTS). The second is to determine benefit of ivabradine treatment. Ivabradine is a drug approved to treat tachycardia in persons with heart failure. The third is to characterize risk factors and outcomes among volunteers with and without LHC. This will include comparison with COVID-19-positive individuals who did not develop long-COVID symptoms.
The study will improve basic and applied knowledge of LHC and its associated cardiovascular and autonomic consequences. Cellular and molecular characterization of LHC and non-LHC participants will be performed with a nested clinical trial for Ivabradine responsiveness on reduction of tachycardia. It is hoped that a greater understanding of LHC, and related autonomic dysfunction in particular will help to identify treatment paradigms and therapeutic targets for improving recovery and enhancing health for those affected.
Eligibility Criteria: For information please visit: Study Page
Participant Expectations: -9 visits over the span of one year
Study procedures include but not limited to: EKGs, tilt table tests, PFTs, blood draws, urine sampling, history and physicals, neurocognitive assessments, ambulatory device monitoring, psychological interviews, surveys, echocardiograms, etc.
If found to have POTS, then participant will be enrolled in the RCT and will be taking IP for the remainder of the study.
This is a fully-in person study.
Each visit is compensated but we do not provide travel reimbursement.
We will not be billing anything to any health insurance providers.
Contact Information: Carrie Hsu (carrie.hsu.ctr@usuhs.edu/202-743-6174)
Priscilla Kobi (priscilla.kobi.ctr@usuhs.edu/202-819-6482)
IRB Number: 21-13822
IRB Approval Date: 07-11-2022
Related Link(s):  Study Page

What About Water?!

Purpose: To understand the influence of water intake on body fat percentage analysis using the new supplemental body fat methods: InBody 770 & dual energy x-ray absorptiometry (DXA).
Eligibility Criteria: 1) Active duty military personnel, 2) Between 18-54 years old, 3) Generally healthy (self-reported)
Participant Expectations: Participant will complete: DXA scan, InBody scan, and Circumference Tape Test; Handgrip strength and isometric mid-thigh pull; Hydration testing; Consume 250 mL, 500 mL, or 1000 mL of water (or no water intake)
Contact Information: 1LT Tina Sergi, tina.e.sergi.mil@health.mil or 301-400-3905
IRB Number: WRNMMC-2023-0435
IRB Approval Date: 10/24/2023

Adjustment disorders in the US military: Addressing Gaps in Knowledge and Practice

Purpose: The purpose of this study is to investigate gaps associated with diagnosing and assessing Adjustment Disorders (AD) in service members. This involves two phases conducted concurrently: (1) establishing a military-specific assessment tool for ADs and (2) exploring provider-focused factors that influence AD diagnosis in military populations for the purpose of modifying the reliable and validated ADNM-20.
Eligibility Criteria: Phase 1C Psychometric Evaluation (Any Active Duty Service Member, 18 or older, English-speaking, and who has not participated in another phase of this study) who: (1) has a diagnosis of Adjustment Disorder alone or Adjustment Disorder with depressed mood, anxiety, or mixed anxiety and depressed mood within the past 12 months OR (2) has never received a diagnosis of Adjustment Disorder or any other mental health or substance use disorders Phase 2b (Providers Only): Provider (e.g., healthcare, behavioral health), age 18 years or older, who diagnoses or treats active duty military service members.
Participant Expectations: Phase 1C (Any Service Member) If you decide to participate in this study you will complete a 20-30 minute packet of online questionnaires, which can also be mailed to you. The questionnaires will ask you about a series of symptoms of various mental health problems to understand how adjustment disorders are experienced in military populations and how they are different from other diagnoses. Phase 2b (Providers Only) If you decide to participate in the study you will complete a short onetime questionnaire that will take approximately 20-30 minutes to complete. The questionnaire will ask you about your attitudes and behaviors as a provider with regards to using a military-specific/focused assessment tool when diagnosing Adjustment Disorders in the Military population.
Contact Information: Dr. Kim Hopkins, WHNP-BC, PhD dawn-kimberly.hopkins.ctr@usuhs.edu 301-295-3457
IRB Number: USUHS.2021-075
IRB Approval Date: 05/21/2021
Related Link(s): Study Page

Exploring the Natural History of Traumatic Brain Injury within a Military Cohort 

Official Title: Exploring the Natural History of Traumatic Brain Injury within a Military Cohort – A Longitudinal Database and Blood Banking Study
Date Window: 4/26/2013 - 4/1/2028
Contact for Details: For more information please call 855-753-3394 or email natural.history1@dvbic.org
Summary: If you served in the military after October 2001, you may be eligible to participate in a reserach study requested by Congress. We are currently recruiting service members and veterans who 1) have incurred a TBI since 2001, 2) incurred a bodily injury that was not a TBI since 2011 or 3) have served at any point since 2001 but were not injured.
The purpose of the study is to increase our understanding of the long term effects of trumatic brain injury on service members and veterans. Participation will include short yearly appointments. Each visit will last either 2 hours or 2 days and will occur once per year for up to 15 years. You may elect to participate only in web-based and telephone measures.

Your participant could contribute to knowledge that could improve the care of your fellow service members and veterans. You may be compensated for your participation.