Low-level Blast ExposureBLESNCT07606651
Blast Overpressure Longitudinal Study
An observational study of Low-level Blast Exposure, run by Uniformed Services University of the Health Sciences at 3 sites in United States.
Trial summary
The goal of this observational study is to learn about the impact of low-level blast exposure in U.S. Special Operations Forces personnel. The main questions it aims to answer are: What advanced brain imaging changes are related to clinical presentation after low-level blast exposure? What are the relationships… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-level Blast Exposure
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2026to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The target population is 250 SOF personnel, particularly those who are regularly exposed to occupational low-level blast exposure. Approximately 10% of the sample will be recruited as a control group of low/no exposure personnel.
Who may be able to join
- Active duty
- U.S. SOF personnel
- 18-50 years old
Who cannot join
- Subjects will be excluded only if their participation will significantly interfere with validity of data collection or safety during the study (e.g., they have conditions that might result in harm or injury during research procedures).
- Example: pregnancy (balance considerations)
- Example: being unable to undergo MRI testing (i.e., they have non-MRI compatible devices, imbedded metal fragments such as shrapnel, and/or severe claustrophobia; these MRI contraindications will be screened using an MRI Safety Questionnaire)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Tony T Yuan, PhD, 214-808-8971, tony.yuan@usuhs.edu
Fort Bragg
Fort Bragg, North Carolina, 28310
Rodney Saunders, MSN, 740-398-1391, rodney.saunders.ctr@usuhs.edu
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, 78236
Carrie W Hoppes, PhD, 571-212-4660, carrie.hoppes.ctr@usuhs.edu
About this study
Official title: Blast Overpressure Longitudinal Exposure Study (BLES)
The goal of this observational study is to learn about the impact of low-level blast exposure in U.S. Special Operations Forces personnel. The main questions it aims to answer are:
What advanced brain imaging changes are related to clinical presentation after low-level blast exposure? What are the relationships between low-level blast exposure and common groups of symptoms after concussion?
Participants will:
- Undergo advanced brain imaging
- Answer questionnaires
- Complete clinical tests
- Provide blood, urine, and saliva samples
- Wear blast sensors
Read the detailed description
Participants in this observational study are active-duty U.S. Special Operations Forces personnel between the ages of 18 and 50. This study is designed to characterize the neurological and clinical effects associated with repeated low-level blast exposure (LLBE) in this population. Concerns have emerged that cumulative exposure to sub-concussive blast overpressure (BOP), even in the absence of a diagnosable concussion, may be associated with subtle changes in brain structure and function over time. Due to the nature of their operational and training environments, Special Operations Forces personnel may experience repeated LLBE and are therefore an important population for longitudinal investigation.
Participation involves in-person assessments and data collection conducted over a period of approximately 4-5 years. The schedule of study activities includes baseline, daily, weekly, monthly, quarterly, and annual assessments. Baseline and annual study visits include advanced magnetic resonance imaging (MRI) and require travel to Walter Reed National Military Medical Center. Specifically, this study includes the use of the Microstructure Anatomy Gradient for Neuroimaging with Ultrafast Scanning (MAGNUS) 3.0 Tesla MRI.
Throughout the study period, participants complete standardized questionnaires and clinical assessments and provide biological samples, including blood, urine, and saliva, at specified intervals. Participants also contribute measures on a daily, weekly, monthly, quarterly, and annual basis. They will wear blast sensors throughout their participation in the study.
The total planned enrollment for the study is approximately 250 participants across multiple sites, with an estimated 60 participants enrolled at Fort Bragg, NC. Enrollment and follow-up are expected to occur over a 4-5 year period.
- Conditions
- Low-level Blast Exposure
- Keywords
- traumatic brain injury, concussion, magnetic resonance imaging, blast overpressure, low-level blast exposure, repeated blast exposure
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High exposure (experimental) | Special Operations Forces personnel with higher occupational blast overpressure exposure as measured by blast sensor(s) | |
| Low/No exposure (control) | Special Operations Forces personnel with lower occupational blast overpressure exposure as measured by blast sensor(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective axonal radii mapping
The primary outcome measure in this study will be effective axonal radii (r_eff) mapping derived from ultra-high performance diffusion magnetic resonance imaging using the MAGNUS system and its correlations to low-level blast exposure.
Measured: At baseline and annually through study completion, an average of 5 years
Secondary outcomes (32)
Ohio State University TBI Identification Method
The Ohio State University TBI Identification Method is a standardized approach for collecting an individual's comprehensive history of traumatic brain injuries through a structured interview lasting 3-5 minutes.
Measured: At baseline and annually through study completion, an average of 5 years
Concussion Clinical Profiles Screening
The Concussion Clinical Profiles Screening (CP Screen) tool will be used to measure the five concussion clinical subtypes (profiles) and two modifiers. The CP Screen is a 29-item post-concussion symptom inventory. Subjects rate the severity of 29 symptoms on a scale from 0 (None [Not experiencing this symptom.]) to 3 (Severe). The CP Screen total score is a sum of the 29 items (range 0 to 87, higher scores mean a worse outcome). Subscale scores range from 0 to 15 for vestibular, ocular-motor, anxiety/mood, and post-traumatic headache (migraine); 0 to 9 for cognitive; 0 to 12 for sleep; and 0 to 6 for cervical spine.
Measured: At baseline and annually through study completion, an average of 5 years
Neurobehavioral Symptom Inventory
The Neurobehavioral Symptom Inventory (NSI) is a 22-item post-concussion symptom inventory. The NSI total score is a sum of the 22 items (range 0 to 88, higher scores mean a worse outcome).
Measured: At baseline and weekly through study completion, an average of 5 years
Headache Impact Test
The Headache Impact Test (HIT-6) is a 6-item assessment of the negative impact of headaches. The HIT-6 total score is a sum of the 6 items (range 36 to 78, higher scores mean a worse outcome).
Measured: At baseline and weekly through study completion, an average of 5 years
modified Military Concussion Readiness Inventory for Dizziness and Balance
The modified Military Concussion Readiness Inventory for Dizziness and Balance (MCRI-DB) is a military-specific measure of the handicapping effects dizziness and imbalance (similar to the Dizziness Handicap Inventory). The modified MCRI-DB total score is a sum of the 25 items (range 0 to 100, higher scores mean a worse outcome).
Measured: At baseline and quarterly through study completion, an average of 5 years
Composite Autonomic Symptom Score (COMPASS) 31
The Composite Autonomic Symptom Score (COMPASS) 31 is a 31-item self-reported evaluation that measures autonomic symptoms across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal (combining constipation, diarrhea, and gastroparesis domains), bladder, and pupillomotor. The COMPASS-31 total score is a sum of the 31 items (range 0 to 100, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a 18-item self-reported evaluation of sleep quality to distinguish between "good" and "poor" sleepers, and identify significant sleep disturbances of various types. There are an additional five items for evaluating sleep quality, as reported by a bed partner/roommate. The PSQI total score is a sum of the 18 items (range 0 to 21, higher scores mean a worse outcome).
Measured: PSQI at baseline and annually through study completion, an average of 5 years
Brief Pittsburgh Sleep Quality Index
The Brief Pittsburgh Sleep Quality Index (B-PSQI) is a 6-item self-reported evaluation of sleep quality to distinguish between "good" and "poor" sleepers, and identify significant sleep disturbances of various types. The B-PSQI total score is a sum of the 6 items (range 0 to 21, higher scores mean a worse outcome).
Measured: B-PSQI monthly through study completion (except at baseline and annually when the 18-item PSQI [see above] will be used), an average of 5 years
STOP-Bang
The STOP-Bang questionnaire will be used as a screening instrument for obstructive sleep apnea. It uses a yes/no checklist for snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and gender (male sex). Scores on the STOP-Bang range from 0 to 8 (higher scores mean a worse outcome) with ≥3 indicating a positive screening.
Measured: At baseline and annually through study completion, an average of 5 years
Neck Disability Index
The Neck Disability Index (NDI) is a 10-item self-reported evaluation that measures how neck pain impacts daily life and the level of self-perceived disability in individuals with neck pain. The NDI total score is a sum of the 10 items (range 0 to 50, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
PTSD Checklist for DSM-5 (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report instrument designed to evaluate the 20 symptoms of PTSD as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The PCL-5 total score is a sum of the 20 items (range 0 to 80, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
General Anxiety Disorder (GAD-7)
The General Anxiety Disorder (GAD-7) is a 7-item assessment for identifying likely cases of generalized anxiety disorder. The GAD-7 total score is a sum of the 7 items (range 0 to 21, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a 9-item assessment for evaluating the presence and severity of depressive symptoms. The PHQ-9 total score is a sum of the 9 items (range 0 to 27, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Quality of Life after Brain Injury (QOLIBRI)
The Quality of Life after Brain Injury (QOLIBRI) evaluates health-related quality of life in individuals following TBI, incorporating the individual's perspective on their health, functioning, and well-being. The QOLIBRI consists of 37 items divided into four scales: Cognition, Self, Daily Life and Autonomy, and Social Relationships. The QOLIBRI total score is a sum of the 37 items (range 0 to 100, higher scores mean a better outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Caffeine Consumption Questionnaire - Revised
The Caffeine Consumption Questionnaire - Revised is a six-page self-report measure to estimate caffeine consumption. This outcome measure can be scored in three ways: a conservative estimate using minimum caffeine concentration values, a mean estimate based on average concentrations, and a liberal estimate using maximum concentration values.
Measured: At baseline and weekly through study completion, an average of 5 years
Supplement Frequency Questionnaire
The Supplement Frequency Questionnaire is a one-page survey that assesses supplement use across 16 categories over the past year. The 16 categories are: multivitamins (one-a-day, B-complex, antioxidant); vitamins A, C, E, B-12, and D; beta-carotene; folic acid; calcium; selenium; iron; zinc; fish oil/omega-3 fatty acids; and garlic. This outcome measure can be scored by calculating total nutrient intake for each nutrient from supplements by multiplying frequency × duration × default dose.
Measured: At baseline and annually through study completion, an average of 5 years
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
The Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) is a screening tool used to identify hazardous drinking and potential alcohol use disorders. The AUDIT-C total score is a sum of the 3 items (range 0 to 12, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Penn State Cigarette Dependence Index
The Penn State Cigarette Dependence Index is a 10-item measure of nicotine dependence. The Penn State Cigarette Dependence Index total score is a sum of the 10 items (range 0 to 20, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Penn State Electronic Cigarette Dependence Index
The Penn State Electronic Cigarette Dependence Index is a 10-item measure of nicotine dependence. The Penn State Electronic Cigarette Dependence Index total score is a sum of the 10 items (range 0 to 20, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Penn State Nicotine Pouch Dependence Index
The Penn State Nicotine Pouch Dependence Index is a 10-item measure of nicotine dependence. The Penn State Nicotine Pouch Dependence Index total score is a sum of the 10 items (range 0 to 20, higher scores mean a worse outcome).
Measured: At baseline and annually through study completion, an average of 5 years
Military Acute Concussion Evaluation 2 (MACE2)
The Military Acute Concussion Evaluation 2 (MACE2) is the standard of care for concussion screening and diagnosis in the military, and consists of: description of incident (potentially concussive event); alteration of consciousness or memory; symptoms; history of concussion, headache disorder or migraine, depression, anxiety, or other behavioral health concerns; cognitive exam; neurological exam; and Vestibular/Ocular Motor Screening (VOMS; see below). The MACE2's multiple measurements will be aggregated to arrive at one reported value - positive or negative.
Measured: At baseline and annually through study completion, an average of 5 years
Military Acute Concussion Evaluation 2 (MACE2) with embedded Vestibular/Ocular Motor Screening (VOMS)
The Vestibular/Ocular Motor Screening (VOMS) is a brief clinical screening tool (<5 minutes) for vestibular and ocular motor symptoms and impairment after concussion and consists of seven items: smooth pursuits, horizontal saccades, vertical saccades, near-point convergence (NPC), horizontal vestibulo-ocular reflex (VOR), vertical VOR, and visual motion sensitivity. The VOMS' multiple measurements will be aggregated to arrive at one reported value - positive or negative.
Measured: At baseline and annually through study completion, an average of 5 years
Sway mobile device application
The Sway mobile device application (Sway Medical, Inc., Tulsa, OK) will be used to assess symptoms, cognition, and balance. Sway's multiple measurements will be aggregated to arrive at one reported value - positive or negative.
Measured: At baseline and weekly through study completion, an average of 5 years
COncussion BALance Test (COBALT)
Subjects will undergo COncussion BALance Test (COBALT) (Bertec Corporation, Columbus, OH) testing. Each of the eight conditions in the manufacturer's research-only protocol will be performed for two 20-sec trials during which errors will be recorded by the clinician and sway velocity will be recorded by the force plate. The COBALT's multiple measurements will be aggregated to arrive at two reported values - sway velocity and number of errors.
Measured: At baseline and quarterly through study completion, an average of 5 years
King-Devick Test
The King-Devick Test (King-Devick technologies, inc., Oak Brook, IL) is a short, timed assessment in which subjects rapidly read aloud single-digit numbers.
Measured: At baseline and weekly through study completion, an average of 5 years
EYE-SYNC®
The EYE-SYNC® (NeuroSync, Inc., Holliston, MA) will be used to administer the Vestibular/Ocular Motor Screening, as well as pro-saccades and anti-saccades.
Measured: At baseline and annually through study completion, an average of 5 years
PLR®-4000
The PLR®-4000 (NeurOptics, Inc., Irving, CA) will be used to measure pupil size and pupillary reactivity. Eight measurements from the device (maximum diameter, minimum diameter, percent change, latency of constriction, constriction velocity, maximum constriction velocity, dilation velocity, and time to reach 75% recovery) will be aggregated to arrive at one reported value - normal or abnormal (in comparison to published normative data).
Measured: At baseline and annually through study completion, an average of 5 years
Automated Neuropsychological Assessment Metrics (v4) Military Expanded
The Military Battery consists of Participant Information (military demographics), Sleepiness Scale, TBI Questionnaire, Mood Scale, Simple Reaction Time, Code Substitution - Learning, Procedural Reaction Time, Mathematical Processing, Matching to Sample, Code Substitution - Delayed, and Simple Reaction Time (Repeated) modules. The ANAM's multiple measurements will be aggregated to arrive at one reported value - normal or abnormal (in comparison to published normative data stratified by age [5-year increments], gender, race/ethnicity and education).
Measured: At baseline and annually through study completion, an average of 5 years
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) is a rapid (approximately 30-minute) assessment of cognitive functioning. A composite score, the Full Scale IQ-4 Subtest (FSIQ-4), ranges from "Very Superior" (≥130) to "Extremely Low/Impaired" (<70) and higher scores mean a better outcome.
Measured: At baseline and annually through study completion, an average of 5 years
Videonystagmography (VNG) / oculomotor and vestibular function testing
Subjects will undergo videonystagmography (VNG) / oculomotor and vestibular function testing (smooth pursuit, horizontal and vertical saccades, caloric testing, ocular and cervical vestibular-evoked myogenic potentials [oVEMP and cVEMP]) performed by a Research Audiologist. The results of this battery of testing will be aggregated to arrive at one reported value - normal or abnormal (in comparison to published normative data).
Measured: At baseline and annually through study completion, an average of 5 years
Video Head Impulse (vHIT)
Subjects will undergo video Head Impulse Test (vHIT) testing with the ICS® Impulse (Natus; Middleton, WI). This is a standard clinical test of the semicircular canals. Vestibulo-ocular reflex gain will be determined using the ratio of the area under the curve of eye velocity relative to the area under the curve of head velocity (after saccade traces are removed) from onset to offset of head velocity.
Measured: At baseline and annually through study completion, an average of 5 years
Wireless Automated Hearing Test System (WAHTS)
Subjects will undergo Wireless Automated Hearing Test System (WAHTS) (WAHTS Hearing LLC; Lebanon, NH) portable, wireless audiometry testing.
Measured: At baseline and annually through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-level Blast ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation, MIT Lincoln Laboratory
- Responsible party
- Sponsor
- Investigators
- Vincent B Ho, MD, Study chair, Uniformed Services University of the Health SciencesTony T Yuan, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606651
- Sponsor's protocol ID
- 25-21750
- Other IDs
- HU00012520052
- Acronym
- BLES
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data may be shared, when permitted by USSOCOM, upon reasonable request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blast Overpressure Longitudinal Exposure Study (BLES)
- ClinicalTrials.gov ID
- NCT07606651
- Acronym / sponsor ID
- BLES / 25-21750
- Conditions
- Low-level Blast Exposure
- Keywords
- traumatic brain injury, concussion, magnetic resonance imaging, blast overpressure, low-level blast exposure, repeated blast exposure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- The Geneva Foundation, MIT Lincoln Laboratory
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the impact of low-level blast exposure in U.S. Special Operations Forces personnel. The main questions it aims to answer are:
What advanced brain imaging changes are related to clinical presentation after low-level blast exposure? What are the relationships between low-level blast exposure and common groups of symptoms after concussion?
Participants will:
- Undergo advanced brain imaging
- Answer questionnaires
- Complete clinical tests
- Provide blood, urine, and saliva samples
- Wear blast sensors
Detailed description
Participants in this observational study are active-duty U.S. Special Operations Forces personnel between the ages of 18 and 50. This study is designed to characterize the neurological and clinical effects associated with repeated low-level blast exposure (LLBE) in this population. Concerns have emerged that cumulative exposure to sub-concussive blast overpressure (BOP), even in the absence of a diagnosable concussion, may be associated with subtle changes in brain structure and function over time. Due to the nature of their operational and training environments, Special Operations Forces personnel may experience repeated LLBE and are therefore an important population for longitudinal investigation.
Participation involves in-person assessments and data collection conducted over a period of approximately 4-5 years. The schedule of study activities includes baseline, daily, weekly, monthly, quarterly, and annual assessments. Baseline and annual study visits include advanced magnetic resonance imaging (MRI) and require travel to Walter Reed National Military Medical Center. Specifically, this study includes the use of the Microstructure Anatomy Gradient for Neuroimaging with Ultrafast Scanning (MAGNUS) 3.0 Tesla MRI.
Throughout the study period, participants complete standardized questionnaires and clinical assessments and provide biological samples, including blood, urine, and saliva, at specified intervals. Participants also contribute measures on a daily, weekly, monthly, quarterly, and annual basis. They will wear blast sensors throughout their participation in the study.
The total planned enrollment for the study is approximately 250 participants across multiple sites, with an estimated 60 participants enrolled at Fort Bragg, NC. Enrollment and follow-up are expected to occur over a 4-5 year period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High exposure (experimental) | – | –Special Operations Forces personnel with higher occupational blast overpressure exposure as measured by blast sensor(s) |
| Low/No exposure (control) | – | –Special Operations Forces personnel with lower occupational blast overpressure exposure as measured by blast sensor(s) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target population is 250 SOF personnel, particularly those who are regularly exposed to occupational low-level blast exposure. Approximately 10% of the sample will be recruited as a control group of low/no exposure personnel.
Key inclusion criteria (3 listed)
- Active duty
- U.S. SOF personnel
- 18-50 years old
Key exclusion criteria (3 listed)
- Subjects will be excluded only if their participation will significantly interfere with validity of data collection or safety during the study (e.g., they have conditions that might result in harm or injury during research procedures).
- Example: pregnancy (balance considerations)
- Example: being unable to undergo MRI testing (i.e., they have non-MRI compatible devices, imbedded metal fragments such as shrapnel, and/or severe claustrophobia; these MRI contraindications will be screened using an MRI Safety Questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effective axonal radii mapping
Time frame: At baseline and annually through study completion, an average of 5 years
The primary outcome measure in this study will be effective axonal radii (r_eff) mapping derived from ultra-high performance diffusion magnetic resonance imaging using the MAGNUS system and its correlations to low-level blast exposure.
32 secondary outcomes
Ohio State University TBI Identification Method
Time frame: At baseline and annually through study completion, an average of 5 years
Concussion Clinical Profiles Screening
Time frame: At baseline and annually through study completion, an average of 5 years
Neurobehavioral Symptom Inventory
Time frame: At baseline and weekly through study completion, an average of 5 years
Headache Impact Test
Time frame: At baseline and weekly through study completion, an average of 5 years
modified Military Concussion Readiness Inventory for Dizziness and Balance
Time frame: At baseline and quarterly through study completion, an average of 5 years
Composite Autonomic Symptom Score (COMPASS) 31
Time frame: At baseline and annually through study completion, an average of 5 years
Pittsburgh Sleep Quality Index
Time frame: PSQI at baseline and annually through study completion, an average of 5 years
Brief Pittsburgh Sleep Quality Index
Time frame: B-PSQI monthly through study completion (except at baseline and annually when the 18-item PSQI [see above] will be used), an average of 5 years
STOP-Bang
Time frame: At baseline and annually through study completion, an average of 5 years
Neck Disability Index
Time frame: At baseline and annually through study completion, an average of 5 years
PTSD Checklist for DSM-5 (PCL-5)
Time frame: At baseline and annually through study completion, an average of 5 years
General Anxiety Disorder (GAD-7)
Time frame: At baseline and annually through study completion, an average of 5 years
Patient Health Questionnaire (PHQ-9)
Time frame: At baseline and annually through study completion, an average of 5 years
Quality of Life after Brain Injury (QOLIBRI)
Time frame: At baseline and annually through study completion, an average of 5 years
Caffeine Consumption Questionnaire - Revised
Time frame: At baseline and weekly through study completion, an average of 5 years
Supplement Frequency Questionnaire
Time frame: At baseline and annually through study completion, an average of 5 years
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Time frame: At baseline and annually through study completion, an average of 5 years
Penn State Cigarette Dependence Index
Time frame: At baseline and annually through study completion, an average of 5 years
Penn State Electronic Cigarette Dependence Index
Time frame: At baseline and annually through study completion, an average of 5 years
Penn State Nicotine Pouch Dependence Index
Time frame: At baseline and annually through study completion, an average of 5 years
Military Acute Concussion Evaluation 2 (MACE2)
Time frame: At baseline and annually through study completion, an average of 5 years
Military Acute Concussion Evaluation 2 (MACE2) with embedded Vestibular/Ocular Motor Screening (VOMS)
Time frame: At baseline and annually through study completion, an average of 5 years
Sway mobile device application
Time frame: At baseline and weekly through study completion, an average of 5 years
COncussion BALance Test (COBALT)
Time frame: At baseline and quarterly through study completion, an average of 5 years
King-Devick Test
Time frame: At baseline and weekly through study completion, an average of 5 years
EYE-SYNC®
Time frame: At baseline and annually through study completion, an average of 5 years
PLR®-4000
Time frame: At baseline and annually through study completion, an average of 5 years
Automated Neuropsychological Assessment Metrics (v4) Military Expanded
Time frame: At baseline and annually through study completion, an average of 5 years
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
Time frame: At baseline and annually through study completion, an average of 5 years
Videonystagmography (VNG) / oculomotor and vestibular function testing
Time frame: At baseline and annually through study completion, an average of 5 years
Video Head Impulse (vHIT)
Time frame: At baseline and annually through study completion, an average of 5 years
Wireless Automated Hearing Test System (WAHTS)
Time frame: At baseline and annually through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. Research data may be shared, when permitted by USSOCOM, upon reasonable request to the Principal Investigator.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent B Ho, MD study chair
Uniformed Services University of the Health Sciences
Tony T Yuan, PhD principal investigator
Uniformed Services University of the Health Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-level Blast Exposure, run by Uniformed Services University of the Health Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tony T Yuan, PhD (214-808-8971, tony.yuan@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective axonal radii mapping (time frame: At baseline and annually through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.