ConcussionNCT02262507
Concussion Device Audiological Measures
A study testing Device Wearing in people with Concussion and Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Traumatic Brain Injury
- What is being tested?
- Device Wearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Normal healthy volunteer
- Able to provide written consent
Who cannot join
- • 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
Show all 11Show fewer
- 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
About this study
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.
Read the detailed description
For the testing sessions, subjects may either come to our testing site or the investigators may bring the testing to their location (e.g. schools, work). The subjects will be fitted with a device around your neck, like a neck tie. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks (IRB# 2013-2240 safety testing performed on this Device). The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie. The methods are utilized in prior approved IRB (2013-2240)..
Station I: Consent to Participate Each participant will review the Institutional Review Board approved consent to participate form prior to data collection. They will be given an adequate amount of time to ask questions to the study coordinator, or the person obtaining consent, and then make their decision to participate or not participate. If they wish to participate, they will be asked to sign the informed consent form. For middle school and high school subjects recruited via the investigators relationship with the schools, this station will be designated to review consent and assent forms to ensure that proper signatures have been obtained.
Station II: Device Fitting and Ultrasound The subjects will be outfitted with the device by a staff member appropriately trained in fitting the device in the proper location.
Station III: Wideband Absorbance and Oto-Acoustic Emissions This station will help determine the effectiveness of the device by measuring the auditory response of a clicking noise that will be non-invasively imparted into the subject's outer ear. For both tests, a soft silicone tip is placed into the outer ear, and sounds are delivered via a miniature speaker. For the wideband absorbance test, absorbed acoustic responses will be monitored to provide information on the operation of the collar device. These are measured as changes in the acoustic absorbance of the ear. For the oto-acoustic emission test, tones or clicks will be presented to the ear with the same soft ear probe and recording microphones pick up the oto-acoustic emission coming back from the outer hair cells of the inner ear. The computer averages and processes the responses in reference to a noise floor across a specified frequency range, displaying the results on the computer screen for the tester. The oto-acoustic emissions test also provides a brief hearing screening to determine if hearing is normal.
Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with increased intracranial pressure, thus this simple, non-invasive exam will provide feedback on the effectiveness of the device.
During the wideband absorbance and oto-acoustic emissions testing the study participants will also be fitted with a compressive circumferential neck collar which can provide variable and specific levels of pressure. The pressure is achieved by inflatable pods that sit adjacent to the trachea affixed to a non-stretch adjustable collar. Manual inflation is regulated and monitored by an experience operator/ technician through a bulb style pump and an electronic gauge. Testing will occur without pressure and then with pressures applied up to 40mmHg.
Station IV: Hearing Assessment Otoscopy will be performed by an audiologist to note any ear blockages, such as wax or drainage for exclusion purposes. The oto-acoustic emissions test will be interpreted to determine if normal responses were obtained in each ear. If abnormal, a hearing screening using pure tone audiometry screening will be provided free of charge. In the event that the hearing screening is determined to be abnormal, the subject will receive the results which may be shared with their primary care provider to determine any need for referral for follow-up. If a subject is seen for follow-up at CCHMC following an abnormal hearing assessment, this visit and any follow up visits will not be paid for by this project and will be subject to insurance billing.
- Conditions
- Concussion, Traumatic Brain Injury
- Being tested
- Device Wearing
- Keywords
- Brain, Hearing, MTBI
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Device Wearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Undergoing Acoustic Reflectance
Number of participants undergoing acoustic reflectance with and without the compression collar
Measured: within single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory D Myer, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262507
- Sponsor's protocol ID
- 2013-5717
- Status last verified
- Nov 2020
- First submitted
- 3 Oct 2014
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concussion Device Audiological Measures
- ClinicalTrials.gov ID
- NCT02262507
- Acronym / sponsor ID
- 2013-5717
- Conditions
- Concussion, Traumatic Brain Injury
- Keywords
- Brain, Hearing, MTBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 9 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For the testing sessions, subjects may either come to our testing site or the investigators may bring the testing to their location (e.g. schools, work). The subjects will be fitted with a device around your neck, like a neck tie. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks (IRB# 2013-2240 safety testing performed on this Device). The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie. The methods are utilized in prior approved IRB (2013-2240)..
Station I: Consent to Participate Each participant will review the Institutional Review Board approved consent to participate form prior to data collection. They will be given an adequate amount of time to ask questions to the study coordinator, or the person obtaining consent, and then make their decision to participate or not participate. If they wish to participate, they will be asked to sign the informed consent form. For middle school and high school subjects recruited via the investigators relationship with the schools, this station will be designated to review consent and assent forms to ensure that proper signatures have been obtained.
Station II: Device Fitting and Ultrasound The subjects will be outfitted with the device by a staff member appropriately trained in fitting the device in the proper location.
Station III: Wideband Absorbance and Oto-Acoustic Emissions This station will help determine the effectiveness of the device by measuring the auditory response of a clicking noise that will be non-invasively imparted into the subject's outer ear. For both tests, a soft silicone tip is placed into the outer ear, and sounds are delivered via a miniature speaker. For the wideband absorbance test, absorbed acoustic responses will be monitored to provide information on the operation of the collar device. These are measured as changes in the acoustic absorbance of the ear. For the oto-acoustic emission test, tones or clicks will be presented to the ear with the same soft ear probe and recording microphones pick up the oto-acoustic emission coming back from the outer hair cells of the inner ear. The computer averages and processes the responses in reference to a noise floor across a specified frequency range, displaying the results on the computer screen for the tester. The oto-acoustic emissions test also provides a brief hearing screening to determine if hearing is normal.
Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with increased intracranial pressure, thus this simple, non-invasive exam will provide feedback on the effectiveness of the device.
During the wideband absorbance and oto-acoustic emissions testing the study participants will also be fitted with a compressive circumferential neck collar which can provide variable and specific levels of pressure. The pressure is achieved by inflatable pods that sit adjacent to the trachea affixed to a non-stretch adjustable collar. Manual inflation is regulated and monitored by an experience operator/ technician through a bulb style pump and an electronic gauge. Testing will occur without pressure and then with pressures applied up to 40mmHg.
Station IV: Hearing Assessment Otoscopy will be performed by an audiologist to note any ear blockages, such as wax or drainage for exclusion purposes. The oto-acoustic emissions test will be interpreted to determine if normal responses were obtained in each ear. If abnormal, a hearing screening using pure tone audiometry screening will be provided free of charge. In the event that the hearing screening is determined to be abnormal, the subject will receive the results which may be shared with their primary care provider to determine any need for referral for follow-up. If a subject is seen for follow-up at CCHMC following an abnormal hearing assessment, this visit and any follow up visits will not be paid for by this project and will be subject to insurance billing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device wearing | Experimental | Device: Device WearingAll 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. |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Normal healthy volunteer
Key exclusion criteria (11 listed)
- • Unable to provide written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device WearingQ30 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 | Device wearing |
Primary outcome
Number of Participants Undergoing Acoustic Reflectance
Time frame: within single day
Number of participants undergoing acoustic reflectance with and without the compression collar
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D Myer, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A study testing Device Wearing in people with Concussion and Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Undergoing Acoustic Reflectance (time frame: within single day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.