The Effects of Chronic Exposure to Low-Level Blasts
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|ClinicalTrials.gov Identifier: NCT01524822|
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : July 25, 2022
- Repeated exposure to explosions may lead to changes in the way that people think or feel. Breachers (people trained to use explosives to get into buildings) are exposed to repeated blasts as part of their job. Researchers want to study how they might be affected by blast exposure. Breachers will be compared with other groups who have different levels of exposure to repeated blasts. Information will also be obtained from spouses or close companions.
- To study the effects of repeated exposure to low-level blasts on thinking, memory, behavior, and brain function.
- Experienced military and civilian breachers, experienced active duty artillery operators, and active duty military without frequent blast exposure, 18 and 60 years of age.
- Spouses or close companions of these individuals.
- Participants will be screened with a physical exam and medical history. Blood samples will be collected and a urine pregnancy test will be required of participants (not companions) before MRI scanning.
- Participants will spend up to 5-days as a NIH clinic outpatient, with about 6 hours of tests each day. Tests will include the following:
- Medical and professional history, with questions about exposures to blasts
- Tests of thinking, memory, and concentration
- Balance tests
- Hearing tests
- Imaging studies, such as magnetic resonance imaging, to look at the brain
- Overnight sleep study to monitor brain waves
- Blood samples
- Participants will return 1 year later for a 3-day followup visit. Some of the tests from before will be repeated. A spouse or close companion (if available) will be asked to complete questionnaires or have a telephone interview.
|Condition or disease|
|Tramatic Brain Injury|
|Study Type :||Observational|
|Actual Enrollment :||66 participants|
|Official Title:||Experienced Breacher Study: Evaluation of the Effects From Chronic Exposure to Low-Level Blast|
|Actual Study Start Date :||July 30, 2012|
exposure to a significant number of concussive evolutions, specifically, exposure to 400 or more within a career, will be considered experienced by the investigators.
exposure to a significant number of breaching blasts, specifically, exposure to 400 breaching blasts or more within a career, will be considered experienced by the investigators
The criterion is met by a person who has both some historical knowledge of the participant and routine interactions outside a work environment.
People not exposed to repeated blasts
- computer-based standardized testing, specifically the ANAM battery and the Simple Reaction Time (SRT) subtest within that battery [ Time Frame: 10 years ]The primary objective for this study is based on anecdotal report of blast-related symptomology and previous and ongoing studies with the breacher community, suggesting a relation between post-concussive symptomology and chronic exposure to low yield blast. Measures employed in this protocol are based on measures used in other protocols in this line of research, measures used inmilitary clinical practice for concussion, and measures outlined in literature as sensitive to brain injury. These include neuroimaging procedures (fMRI, DTI, SWI, and Gadolinium contrast), neurocognitive testing, and vestibular testing.
- blood draw and analysis for biomarkers of brain injury and tests of peripheral auditory functioning and polysomnography to address potential confounds. [ Time Frame: 10 years ]The secondary objectives for this study are intended to be complementary to the primary research questions and are considered important supporting data. These include blood analysis for biomarkers of brain injury, tests of peripheral auditory functioning, and polysomnography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524822
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Eric M Wassermann, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|