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

Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar

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: NCT04068883
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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. 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.


Condition or disease Intervention/treatment Phase
MTBI - Mild Traumatic Brain Injury Concussion, Mild Other: Q collar Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Collar group
group of athletes that will wear the collar device
Other: Q collar
An externally-worn medical device that applies mild jugular compression

No Intervention: Non Collar group
group of athletes that will not wear the collar device



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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:   13 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 13 years or older and a participant on a high school football or soccer 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
  • Prothrombotic or hyperthrombotic condition
  • Cerebral cavernous malformation
  • Players not medically cleared to play sports

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): NCT04068883


Locations
Layout table for location information
United States, Ohio
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Cincinnati 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 Cincinnati Childrens Hospital
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Informed Consent Form  [PDF] July 6, 2018
Study Protocol  [PDF] February 19, 2020

Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04068883    
Other Study ID Numbers: 2018-1123
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating