이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Blast Overpressure Longitudinal Study (BLES)

2026년 5월 18일 업데이트: Uniformed Services University of the Health Sciences

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

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

250

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Maryland
      • Bethesda, Maryland, 미국, 20889
        • Walter Reed National Military Medical Center
        • 연락하다:
    • North Carolina
      • Fort Bragg, North Carolina, 미국, 28310
    • Texas
      • San Antonio, Texas, 미국, 78236
        • Wilford Hall Ambulatory Surgical Center
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

  • Active duty
  • U.S. SOF personnel
  • 18-50 years old

Exclusion Criteria:

  • 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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Effective axonal radii mapping
기간: 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.
At baseline and annually through study completion, an average of 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Ohio State University TBI Identification Method
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Concussion Clinical Profiles Screening
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Neurobehavioral Symptom Inventory
기간: At baseline and weekly through study completion, an average of 5 years
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).
At baseline and weekly through study completion, an average of 5 years
Headache Impact Test
기간: At baseline and weekly through study completion, an average of 5 years
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).
At baseline and weekly through study completion, an average of 5 years
modified Military Concussion Readiness Inventory for Dizziness and Balance
기간: At baseline and quarterly through study completion, an average of 5 years
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).
At baseline and quarterly through study completion, an average of 5 years
Composite Autonomic Symptom Score (COMPASS) 31
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Pittsburgh Sleep Quality Index
기간: PSQI at baseline and annually through study completion, an average of 5 years
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).
PSQI at baseline and annually through study completion, an average of 5 years
Brief Pittsburgh Sleep Quality Index
기간: 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
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).
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
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Neck Disability Index
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
PTSD Checklist for DSM-5 (PCL-5)
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
General Anxiety Disorder (GAD-7)
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Patient Health Questionnaire (PHQ-9)
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Quality of Life after Brain Injury (QOLIBRI)
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Caffeine Consumption Questionnaire - Revised
기간: At baseline and weekly through study completion, an average of 5 years
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.
At baseline and weekly through study completion, an average of 5 years
Supplement Frequency Questionnaire
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Penn State Cigarette Dependence Index
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Penn State Electronic Cigarette Dependence Index
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Penn State Nicotine Pouch Dependence Index
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Military Acute Concussion Evaluation 2 (MACE2)
기간: At baseline and annually through study completion, an average of 5 years
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.
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)
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Sway mobile device application
기간: At baseline and weekly through study completion, an average of 5 years
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.
At baseline and weekly through study completion, an average of 5 years
COncussion BALance Test (COBALT)
기간: At baseline and quarterly through study completion, an average of 5 years
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.
At baseline and quarterly through study completion, an average of 5 years
King-Devick Test
기간: At baseline and weekly through study completion, an average of 5 years
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.
At baseline and weekly through study completion, an average of 5 years
EYE-SYNC®
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
PLR®-4000
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Automated Neuropsychological Assessment Metrics (v4) Military Expanded
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Videonystagmography (VNG) / oculomotor and vestibular function testing
기간: At baseline and annually through study completion, an average of 5 years
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).
At baseline and annually through study completion, an average of 5 years
Video Head Impulse (vHIT)
기간: At baseline and annually through study completion, an average of 5 years
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.
At baseline and annually through study completion, an average of 5 years
Wireless Automated Hearing Test System (WAHTS)
기간: At baseline and annually through study completion, an average of 5 years
Subjects will undergo Wireless Automated Hearing Test System (WAHTS) (WAHTS Hearing LLC; Lebanon, NH) portable, wireless audiometry testing.
At baseline and annually through study completion, an average of 5 years

기타 결과 측정

결과 측정
측정값 설명
기간
quantitative EEG via the NeuroCatch®
기간: At baseline and quarterly through study completion, an average of 5 years
Cognition will be explored using quantitative EEG via the NeuroCatch® (NeuroCatch Inc., Canada) brain vital sign framework. This framework includes three event-related brain potentials (ERPs): auditory N100 (auditory sensation), auditory oddball P300 (basic attention), and auditory speech processing N400 (cognitive processing). NeuroCatch's multiple measurements will be aggregated to arrive at one reported value - normal or abnormal.
At baseline and quarterly through study completion, an average of 5 years
Blast sensor-measurement of blast exposure(s)
기간: Daily through study completion, an average of 5 years
Subjects will wear blast sensors continuously during training for the duration of their study participation. The blast sensors' multiple measurements will be aggregated to arrive at one reported value - total exposure (number of exposure events exceeding 4psi).
Daily through study completion, an average of 5 years
Self-report of blast exposure(s)
기간: Daily through study completion, an average of 5 years
Self-report of environment (i.e., indoor/outdoor, under overhang, etc.), role (shooter/breacher, observer, instructor), position (i.e., prone supported, prone unsupported, kneeling, standing, etc.), weapon (i.e., make/model, caliber, etc.), number of rounds, date/time, and duration of training will also be collected on training days. The questionnaire-based self-report of blast exposure(s) will be aggregated to arrive at one reported value - estimated total exposure (number of exposure events).
Daily through study completion, an average of 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Uniformed Services University of the Health Sciences

협력자

The Geneva Foundation
MIT Lincoln Laboratory

수사관

  • 수석 연구원: Tony T Yuan, PhD, Uniformed Services University of the Health Sciences
  • 연구 의자: Vincent B Ho, MD, Uniformed Services University of the Health Sciences

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2030년 8월 1일

연구 완료 (추정된)

2030년 8월 1일

연구 등록 날짜

최초 제출

2026년 3월 24일

QC 기준을 충족하는 최초 제출

2026년 5월 18일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 25-21750
  • HU00012520052 (기타 보조금/기금 번호: U.S. Special Operations Command)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Research data may be shared, when permitted by USSOCOM, upon reasonable request to the Principal Investigator.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다