N/A
N=410
Concussion Device Audiological Measures
Concussion · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02262507 ↗Enrolled (actual)
410
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants Undergoing Acoustic Reflectance — 410; 410 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device Wearing (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Undergoing Acoustic Reflectance |
410; 410 | <0.05 sig |
Summary
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC (Q30). Initial research suggests that the Device has the potential to reduce the likelihood of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is that the investigators need a physiologic, non-invasive method to evaluate the brain responses to mild jugular compression across multiple age groups. To determine this with MR imaging is currently cost prohibitive. The investigators pilot data from the parent IRB indicates a consistent response measured via wideband absorbance in young adults. Therefore, a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ this technology across a wide range of ages.
Eligibility Criteria
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 head trauma
- Hydrocephalus
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Active concussion symptoms
- Ventricular shunt or neurologic condition
- Internal or external hardware that has been surgically placed in the neck
- Any altered level of consciousness
- Inability to sit still for 10 minutes
Data sourced from ClinicalTrials.gov (NCT02262507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.