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| ID | Type | Description | Link |
|---|---|---|---|
| 12-N-0065 |
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
| Naval Medical Research Center | FED |
Background:
- 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:
Design:
The purpose of this study is to evaluate the cognitive and neurophysiological effects of chronic exposure to repeated low-level blast overpressure. Previous studies show converging evidence for a neurophysiological effect from cumulative exposure to blast, which is consistent with subjective reports of cognitive impairment by individuals trained to use explosives to gain entry to structures (breachers). This study will expand on these findings by examining a larger cohort of experienced breachers and artillery personnel who may be incurring a cumulative effect of low-level blast exposure over the course of several years. We will evaluate up to 20 participants from each of three groups: breachers, artillery personnel, and unexposed individuals. Additionally, we will ask each of the above to bring a close companion for a set of questionnaires and an interview to capture changes in functioning that participants may not be able to self-assess. Participants will travel to the NIH for evaluation of cognitive and neurophysiological measures. The procedures include neuropsychological testing, blood analysis for biomarkers, vestibular and auditory testing, and neuroimaging studies using diffusion tensor imaging, susceptibility weighted imaging, perfusion imaging, functional magnetic resonance imaging, and, where there is evidence of a sleep disorder, polysomnography. This study will be conducted in collaboration with the Naval Medical Research Center (NMRC) and the Walter Reed Army Institute of Research (WRAIR) under a Research Collaborative Agreement. The complementary DoD protocol will be reviewed by the DoD IRB and includes this NIH protocol. The complementary DoD protocol includes data collection at field settings, activity NIH is not engaged in and not described in this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artillery personnel | exposure to a significant number of concussive evolutions, specifically, exposure to 400 or more within a career, will be considered experienced by the investigators. | ||
| Breachers | 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 | ||
| Companions | The criterion is met by a person who has both some historical knowledge of the participant and routine interactions outside a work environment. | ||
| Unexposed | People not exposed to repeated blasts |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| blood draw and analysis for biomarkers of brain injury and tests of peripheral auditory functioning and polysomnography to address potential confounds. | 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. |
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EXPERIMENTAL GROUP: BREACHERS
EXPERIMENTAL GROUP 2: ARTILLERY
CONTROL GROUP: UNEXPOSED
COMPANION GROUP
EXCLUSION CRITERIA:
BREACHERS
History of moderate or more severe brain injury with loss of consciousness greater than 5 minutes
Current diagnosis of other CNS disorder (mild to severe)
Any cardiac, respiratory, or other medical condition that may affect cerebral metabolism
MRI contraindications
ARTILLERY & UNEXPOSED
-Parallel to exclusion criteria for the breacher group, with the addition of exposure to breaching blast (greater than 40 individual blasts) for the Artillery Group and exposure to any blast (greater than 40 individual blasts) for the Unexposed Group.
COMPANION GROUP
-None
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120 total: 20 breachers, 20 artillery, 20 unexposed controls, and 60 companions
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| Name | Affiliation | Role |
|---|---|---|
| Eric M Wassermann, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12638101 | Background | 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. | |
| 17561594 | Background | Bonnet MH, Arand DL. EEG arousal norms by age. J Clin Sleep Med. 2007 Apr 15;3(3):271-4. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 10 years |
| 9504600 | Background | 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. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |