Tramatic Brain InjuryNCT01524822
The Effects of Chronic Exposure to Low-Level Blasts
An observational study of Tramatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tramatic Brain Injury
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 120 total: 20 breachers, 20 artillery, 20 unexposed controls, and 60 companions
Who may be able to join
- 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.
- EXPERIMENTAL GROUP 2: ARTILLERY
- Active duty and veterans who have left active duty within the previous five years
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- Matched to the breacher group 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: 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 )
Who cannot join
- 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
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- Claustrophobia
- Inability to lie supine for up to 2 hours in the MRI scanner
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Experienced Breacher Study: Evaluation of the Effects From Chronic Exposure to Low-Level Blast
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.
Read more
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....
Read the detailed description
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.
- Conditions
- Tramatic Brain Injury
- Keywords
- Military, Traumatic Brain Injury, Cognitive Testing, Neuroimaging, Natural History, Brain Function
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study start30 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tramatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Naval Medical Research Center
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524822
- Sponsor's protocol ID
- 120065
- Other IDs
- 12-N-0065
- Status last verified
- 14 Mar 2023
- First submitted
- 31 Jan 2012
- Last updated
- 17 Mar 2023
- Results posted
- No
Publications
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.
PubMed 12638101Bonnet MH, Arand DL. EEG arousal norms by age. J Clin Sleep Med. 2007 Apr 15;3(3):271-4.
PubMed 17561594El-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.
PubMed 9504600
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experienced Breacher Study: Evaluation of the Effects From Chronic Exposure to Low-Level Blast
- ClinicalTrials.gov ID
- NCT01524822
- Acronym / sponsor ID
- 120065
- Conditions
- Tramatic Brain Injury
- Keywords
- Military, Traumatic Brain Injury, Cognitive Testing, Neuroimaging, Natural History, Brain Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Naval Medical Research Center
- Study start
- 30 Jul 2012 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 120 total: 20 breachers, 20 artillery, 20 unexposed controls, and 60 companions
Key inclusion criteria (16 listed)
- 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.
- EXPERIMENTAL GROUP 2: ARTILLERY
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Background: PubMed 12638101Basford 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.
- Background: PubMed 17561594Bonnet MH, Arand DL. EEG arousal norms by age. J Clin Sleep Med. 2007 Apr 15;3(3):271-4.
- Background: PubMed 9504600El-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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tramatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
computer-based standardized testing, specifically the ANAM battery and the Simple Reaction Time (SRT) subtest within that battery (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524822, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.