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The Effects of Chronic Exposure to Low-Level Blasts
This study is currently recruiting participants.
Verified May 1, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Naval Medical Research Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01524822
First received: January 31, 2012
Last updated: May 9, 2017
Last verified: May 1, 2017
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Purpose
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:
- 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.
Design:
- 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 |
|---|
| Tramatic Brain Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Other |
| Official Title: | Experienced Breacher Study: Evaluation of the Effects From Chronic Exposure to Low-Level Blast |
Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Primary Outcome Measures:
- The primary outcomes of this study will be the data collected from the neuropsychological tests, blood serum analysis, neuroimaging sessions, and vestibular and auditory tests. These measures were selected for their sensitivity to brain injury.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 20, 2012 |
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 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 control 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, imaging with Gadolinium contrast, functional magnetic resonance imaging, and, where there is evidence of a sleep disorder, polysomnography. Participants will also be invited back for a 1-year, follow-up assessment to look for progression of any changes or differences from the control groups. 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 (RCA). 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
- INCLUSION CRITERIA:
EXPERIMENTAL GROUP: BREACHERS
- Active duty and veterans who have left active duty within the previous five years or civilian law enforcement personnel
- Ages 18 60 (age range for an active duty military population)
- At least 4 years of experience in the breaching profession and actively involved in breacher training and/or operations (minimum of annual exposure). An alternate criterion to years of breacher experience is 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.
CONTROL GROUP 1: ARTILLERY
- Active duty and veterans who have left active duty within the previous five years
- Matched to the experimental group (breachers) in terms of age, gender, and operational experience. Operational experience is defined as years of experience actively involved in artillery operations and/or number of artillery evolutions.
- At least 4 years experience with exposure to concussive environments not related to blast (minimum of annual exposure). An alternate criterion to years of experience is exposure to a significant number of concussive evolutions, specifically, exposure to 400 or more within a career, will be considered experienced by the investigators.
CONTROL GROUP 2: UNEXPOSED
- Active duty and veterans who have left active duty within the previous five years
- Matched to the experimental group (breachers) in terms of age, gender, and operational experience. Operational experience is defined as years of experience actively involved in military or law enforcement operations with the condition that operations include direct mission engagement roles rather than support roles. Military deployment or law enforcement patrol are examples of direct mission engagement roles and shore logistics or office based call center are examples of support roles.
COMPANION GROUP
- Spouse, close family member, or other living partner of an experimental or control group participant. The criterion is met by a person who has both some historical knowledge of the participant and routine interactions outside a work environment.
- Over 18 years of age
- Knowledge of the experimental or control group participant s daily functioning
- Companions who are unable to travel to NIH may participate remotely ( off-site companion )
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
- Metal in the body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye
- Claustrophobia
- Inability to lie supine for up to 2 hours in the MRI scanner
CONTROL GROUPS 1 & 2: 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524822
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524822
Contacts
| Contact: Kristine Dell | (301) 496-5829 | kristine.dell@nih.gov | |
| Contact: Eric M Wassermann, M.D. | (301) 496-0151 | wassermanne@ninds.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Walter Reed Army Institute of Research (WRAIR)
Naval Medical Research Center
Investigators
| Principal Investigator: | Eric M Wassermann, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT01524822 History of Changes |
| Other Study ID Numbers: |
120065 12-N-0065 |
| Study First Received: | January 31, 2012 |
| Last Updated: | May 9, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
|
Military Traumatic Brain Injury Cognitive Testing Neuroimaging Brain Function |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 28, 2017