MTBI - Mild Traumatic Brain InjuryNCT04068883
Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
A study testing Q collar in people with MTBI - Mild Traumatic Brain Injury and Concussion, Mild, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury, Concussion, Mild
- What is being tested?
- Q collar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal healthy volunteer
- Able to provide written consent
- Must be 13 years or older and a participant on a high school football or soccer team
Who cannot join
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season 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)
Show all 14Show fewer
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
- Prothrombotic or hyperthrombotic condition
- Cerebral cavernous malformation
- Players not medically cleared to play sports
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation.
Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for:
Read more
- Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
- Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users.
In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.
Read the detailed description
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 incurred 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 Sports Science, LLC (Q30). Preliminary research indicates that the Device has the potential to reduce the likelihood of alterations to brain microstructure. The currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities, Study IDs: 2013-2240, 2016-7948, 2014-5009, 2016-9625, 2016-0988, and 2015-2205 Institutional Review Board - Federalwide Assurance #00002988). FDA has determined that this device is a nonsignificant risk (NSR) device study because it does not meet the definition of a significant risk (SR) device under § 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812).
This study will investigate the effectiveness of this device in high school athletes playing a collision sport such as football or soccer. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. Male football players and female soccer players will be included in this investigation. All participants may be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. This accelerometer will be affixed with an adhesive patch,(which will be placed behind the ear, to measure the magnitude of every impact to the head sustained by the athlete Effectiveness of the device will be determined via differences in longitudinal brain imaging and behavioral assessments following competitive football and soccer participation. The investigators will also enroll a group of athletes involved in a non-contact sport (such as cross-country) to act as controls.
- Being tested
- Q collar
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q collarOther
An externally-worn medical device that applies mild jugular compression
| Study group | Role | What they receive |
|---|---|---|
| Collar group | Experimental | group of athletes that will wear the collar device Receives: Other: Q collar |
| Non Collar group | No intervention | group of athletes that will not wear the collar device |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBSS measured change in axial diffusivity pre to post season
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
Measured: 6 months
TBSS measured change in radial diffusivity pre to post season
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
Measured: 6 months
TBSS measured change in mean diffusivity pre to post season
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups
- Masking
- None (open label)
- Enrolment
- 488 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, Cincinnati Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068883
- Sponsor's protocol ID
- 2018-1123
- Status last verified
- Aug 2020
- First submitted
- 27 Dec 2018
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
- ClinicalTrials.gov ID
- NCT04068883
- Acronym / sponsor ID
- 2018-1123
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation.
Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for:
- Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
- Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users.
In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.
Detailed description
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 incurred 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 Sports Science, LLC (Q30). Preliminary research indicates that the Device has the potential to reduce the likelihood of alterations to brain microstructure. The currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities, Study IDs: 2013-2240, 2016-7948, 2014-5009, 2016-9625, 2016-0988, and 2015-2205 Institutional Review Board - Federalwide Assurance #00002988). FDA has determined that this device is a nonsignificant risk (NSR) device study because it does not meet the definition of a significant risk (SR) device under § 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812).
This study will investigate the effectiveness of this device in high school athletes playing a collision sport such as football or soccer. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. Male football players and female soccer players will be included in this investigation. All participants may be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. This accelerometer will be affixed with an adhesive patch,(which will be placed behind the ear, to measure the magnitude of every impact to the head sustained by the athlete Effectiveness of the device will be determined via differences in longitudinal brain imaging and behavioral assessments following competitive football and soccer participation. The investigators will also enroll a group of athletes involved in a non-contact sport (such as cross-country) to act as controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups
| Arm | Type | Receives |
|---|---|---|
| Collar group | Experimental | Other: Q collargroup of athletes that will wear the collar device |
| Non Collar group | No intervention | –group of athletes that will not wear the collar device |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Normal healthy volunteer
- Able to provide written consent
- Must be 13 years or older and a participant on a high school football or soccer team
Key exclusion criteria (14 listed)
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season 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
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 |
|---|---|---|
| Q collarAn externally-worn medical device that applies mild jugular compression | Other | Collar group |
Primary outcome
TBSS measured change in axial diffusivity pre to post season
Time frame: 6 months
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
TBSS measured change in radial diffusivity pre to post season
Time frame: 6 months
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
TBSS measured change in mean diffusivity pre to post season
Time frame: 6 months
Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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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
Cincinnati Childrens Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q collar in people with MTBI - Mild Traumatic Brain Injury and Concussion, Mild, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
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 3 inclusion and 14 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 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TBSS measured change in axial diffusivity pre to post season (time frame: 6 months). The study lists 3 primary outcomes in all. 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 24 Aug 2020.