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Набор скоро начнётся NCT07606651

Blast Overpressure Longitudinal Study

Наблюдательное Low-level Blast Exposure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Low-level Blast Exposure. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Blast Overpressure Longitudinal Exposure Study (BLES)

Обзор

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

Подробное описание

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.

Первичные конечные точки

  • Effective axonal radii mapping [Срок оценки: At baseline and annually through study completion, an average of 5 years]
Вторичные конечные точки (12)
  • Ohio State University TBI Identification Method [Срок оценки: At baseline and annually through study completion, an average of 5 years]
  • Concussion Clinical Profiles Screening [Срок оценки: At baseline and annually through study completion, an average of 5 years]
  • Neurobehavioral Symptom Inventory [Срок оценки: At baseline and weekly through study completion, an average of 5 years]
  • Headache Impact Test [Срок оценки: At baseline and weekly through study completion, an average of 5 years]
  • modified Military Concussion Readiness Inventory for Dizziness and Balance [Срок оценки: At baseline and quarterly through study completion, an average of 5 years]
  • Composite Autonomic Symptom Score (COMPASS) 31 [Срок оценки: At baseline and annually through study completion, an average of 5 years]
  • Pittsburgh Sleep Quality Index [Срок оценки: PSQI at baseline and annually through study completion, an average of 5 years]
  • Brief Pittsburgh Sleep Quality Index [Срок оценки: 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 [Срок оценки: At baseline and annually through study completion, an average of 5 years]
  • Neck Disability Index [Срок оценки: At baseline and annually through study completion, an average of 5 years]
  • PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: At baseline and annually through study completion, an average of 5 years]
  • General Anxiety Disorder (GAD-7) [Срок оценки: At baseline and annually through study completion, an average of 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Walter Reed National Military Medical Center — Bethesda
  • Fort Bragg — Fort Bragg
  • Wilford Hall Ambulatory Surgical Center — San Antonio

Идентификаторы

NCT: NCT07606651 · 25-21750 · HU00012520052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗