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临床试验/NCT07606651
NCT07606651尚未招募不适用

Blast Overpressure Longitudinal Exposure Study (BLES)

Uniformed Services University of the Health Sciences3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
3

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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