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NCT01524822 · ClinicalTrials.gov registry record
The Effects of Chronic Exposure to Low-Level Blasts
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 66
- Enrollment target
NCT01524822: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01524822 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01524822 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 66 participants
- Enrollment target
Study 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. 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....
Primary Outcome
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 incl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-07-30 |
What the finished NCT01524822 record still lists
NCT01524822 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01524822 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01524822 about?
NCT01524822 is a clinical study titled "The Effects of Chronic Exposure to Low-Level Blasts". 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. Br...
What is the current status of trial NCT01524822?
This trial is currently completed. The enrollment target is 66 participants. The study started on 2012-07-30.
Who is sponsoring clinical trial NCT01524822?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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