CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 410 enrolled
Drug / intervention
Device Wearingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02262507
NCT02262507N/ACompleted

Concussion Device Audiological Measures

Children's Hospital Medical Center, Cincinnati·interventional·Posted Oct 13, 2014·Updated Dec 9, 2020

In Brief

A clinical study evaluating Device Wearing for Concussion and Traumatic Brain Injury. Completed, enrolled 410 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 13, 2014
Enrollment StartSep 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.7 years ago

Interventions

Device Wearingdevice

Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Each subject will undergo repeat oto-acoustic measures both wearing the device and not wearing the device