NCT01524822|Completed
The Effects of Chronic Exposure to Low-Level Blasts
Experienced Breacher Study: Evaluation of the Effects From Chronic Exposure to Low-Level Blast
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Experienced Breacher Study: Evaluation of the Effects From Chronic Exposure to Low-Level Blast
Sponsor study identifier
Secondary identifiers
observational
66
1 country
1
Study Start
July 30, 2012
Actual (reported)Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedBackground: \- 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. Objectives: \- To study the effects of repeated exposure to low-level blasts on thinking, memory, behavior, and brain function. Eligibility:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2012
Actual (reported)February 2, 2012
Actual (reported)July 30, 2012
Actual (reported)computer-based standardized testing, specifically the ANAM battery and the Simple Reaction Time (SRT) subtest within that battery
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.
10 years
blood draw and analysis for biomarkers of brain injury and tests of peripheral auditory functioning and polysomnography to address potential confounds.
10 years
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
120 total: 20 breachers, 20 artillery, 20 unexposed controls, and 60 companions
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Basford JR, Chou LS, Kaufman KR, Brey RH, Walker A, Malec JF, Moessner AM, Brown AW. An assessment of gait and balance deficits after traumatic brain injury. Arch Phys Med Rehabil. 2003 Mar;84(3):343-9. doi: 10.1053/apmr.2003.50034.
Bonnet MH, Arand DL. EEG arousal norms by age. J Clin Sleep Med. 2007 Apr 15;3(3):271-4.
El-Kashlan HK, Shepard NT, Asher AM, Smith-Wheelock M, Telian SA. Evaluation of clinical measures of equilibrium. Laryngoscope. 1998 Mar;108(3):311-9. doi: 10.1097/00005537-199803000-00002.
Eric M Wassermann, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
66 participants (actual enrollment reported by the registry).
First Submitted
January 31, 2012
First Posted
February 2, 2012
Study Start
July 30, 2012
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
March 17, 2023
Record last verified: 2023-03-14
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Source: ClinicalTrials.gov.
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