Concussion Device Audiological Measures

NCT02262507 | Completed Results DMC

• 1 other identifier: 2013-5717
• Study Type: interventional
• Target: 410
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Concussion; Traumatic Brain Injury

Keywords

Brain; Hearing; MTBI

Outcome Measures

Primary Outcomes (1)

• Number of Participants Undergoing Acoustic Reflectance

  Number of participants undergoing acoustic reflectance with and without the compression collar

  within single day

Study Arms (1)

Device wearing

EXPERIMENTAL

All subjects who meet the study criteria and volunteer to participate will be included in the study. Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device. The intervention will be the auto-acoustic measurement - taken while wearing the collar and then again when not wearing the collar.

Device: Device Wearing

Interventions

Device Wearing DEVICE

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

Device wearing

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal healthy volunteer
• Able to provide written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. Gregory Myer
• Organization: Cincinnati Childrens Hospital Sports Medicine

greg.myer@cchmc.org

513-636-0249

Study Officials

• Gregory D Myer, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 13, 2014
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share