Protection Against Potential Brain Injury During Competitive Football
Novel Protection Against Potential Brain Injury During Competitive Football Head Impacts
1 other identifier
interventional
62
1 country
1
Brief Summary
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. 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, This study will investigate the effectiveness of this device in high school athletes playing a collision sport such as football. The use of helmets during such a high-risk sport will allow for collision measurement devices to be embedded in the helmet and will not affect play or fit of equipment. 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. The helmets of all participants will be outfitted with an accelerometer which will 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 functional testing following competitive football participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
December 9, 2020
CompletedDecember 9, 2020
November 1, 2020
1.6 years
May 28, 2015
July 24, 2020
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Determine Average Number of Hits Between Groups
monitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
5 months
Number of Participants Undergoing EEG Assessment
determine the number of subjects in the collar group and the non collar group that underwent EEG assessment
5 months
Change in Fractional Anisotropy (FA)
Change in fractional anisotropy (FA) from Pre to Post season
6 months
Study Arms (2)
Subjects Wearing the Q Collar
EXPERIMENTALSubjects wearing the Q collar throughout the football season
Subjects Not Wearing the Q Collar
NO INTERVENTIONControl group of subjects not wearing the q collar
Interventions
The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
Eligibility Criteria
You may qualify if:
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on varsity level high school football team
You may not qualify if:
- 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)
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (2)
Yuan W, Leach J, Maloney T, Altaye M, Smith D, Gubanich PJ, Barber Foss KD, Thomas S, DiCesare CA, Kiefer AW, Myer GD. Neck Collar with Mild Jugular Vein Compression Ameliorates Brain Activation Changes during a Working Memory Task after a Season of High School Football. J Neurotrauma. 2017 Aug 15;34(16):2432-2444. doi: 10.1089/neu.2016.4834. Epub 2017 Jun 8.
PMID: 28437225DERIVEDMyer GD, Yuan W, Barber Foss KD, Thomas S, Smith D, Leach J, Kiefer AW, Dicesare C, Adams J, Gubanich PJ, Kitchen K, Schneider DK, Braswell D, Krueger D, Altaye M. Analysis of head impact exposure and brain microstructure response in a season-long application of a jugular vein compression collar: a prospective, neuroimaging investigation in American football. Br J Sports Med. 2016 Oct;50(20):1276-1285. doi: 10.1136/bjsports-2016-096134. Epub 2016 Jun 15.
PMID: 27307271DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kim Foss
- Organization
- Cincinnati Childrens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory D Myer, PhD
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
March 2, 2016
Study Start
May 1, 2015
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
December 9, 2020
Results First Posted
December 9, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share
Results will be published however individual participant data will remain secure.