Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protection Against Potential Brain Injury During Competitive Football

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696200
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Concussion Device: Q Collar Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Novel Protection Against Potential Brain Injury During Competitive Football Head Impacts
Study Start Date : May 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Subjects Wearing the Q Collar
Subjects wearing the Q collar throughout the football season
Device: Q Collar
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.

No Intervention: Subjects Not Wearing the Q Collar
Control group of subjects not wearing the q collar



Primary Outcome Measures :
  1. Determine longitudinal changes in brain structure using MRI [ Time Frame: 5 months ]
    monitor longitudinal changes in brain structure 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.

  2. Determine longitudinal changes in brain function using EEG [ Time Frame: 5 months ]
    monitor longitudinal changes in brain 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.


Secondary Outcome Measures :
  1. determine Concussion Incidence [ Time Frame: 5 months ]
    Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal healthy volunteer
  • Able to provide written consent
  • Must be 14 years or older and a participant on varsity level high school football team

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696200


Locations
Layout table for location information
United States, Ohio
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Gregory D Myer, PhD Children's Hospital Medical Center, Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02696200    
Other Study ID Numbers: 2015-2205
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be published however individual participant data will remain secure.
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Concussion
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries