Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/26/2017 |
| Start Date: | December 2016 |
| End Date: | December 2017 |
The purpose of the study is to monitor changes in brain structure and function between the
pre-training and post-training, in a population of tactical team members wearing the Device
and compared to a similar population not wearing the device. Secondly, the purpose is to
determine the protection of the device relative to amount and magnitude of sustained head
impacts.
pre-training and post-training, in a population of tactical team members wearing the Device
and compared to a similar population not wearing the device. Secondly, the purpose is to
determine the protection of the device relative to amount and magnitude of sustained head
impacts.
This study will investigate the effectiveness of this device in tactical team members exposed
to blast waves during tactical training. Subjects participating in this study will be
randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2)
Non-device wearing during the tactical training. The helmets of all participants will be
outfitted with an accelerometer which will measure the magnitude of every concussive blast
wave sustained by the subject. Effectiveness of the device will be determined via differences
in brain MRI and EEG, vision and hearing testing prior to and following standardized
breaching and diversionary device scenario training.
to blast waves during tactical training. Subjects participating in this study will be
randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2)
Non-device wearing during the tactical training. The helmets of all participants will be
outfitted with an accelerometer which will measure the magnitude of every concussive blast
wave sustained by the subject. Effectiveness of the device will be determined via differences
in brain MRI and EEG, vision and hearing testing prior to and following standardized
breaching and diversionary device scenario training.
Inclusion Criteria:
- Normal healthy volunteer
- Able to provide written consent
Exclusion Criteria:
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma
as indicated through pre-tactical training screening:
- Medical contraindications to restriction of venous outflow via the internal jugular
veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension)
- Hydrocephalus
- Recent penetrating brain trauma (within 6 months)
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Gregory D Myer, PhD
Phone: 513-636-5971
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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