Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 18 for:    citadel

Understanding Concussion/Mild Traumatic Brain Injury

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: NCT03381638
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Blinktbi, Inc.

Brief Summary:
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.

Condition or disease Intervention/treatment
Traumatic Brain Injury Concussion, Brain Device: Blink Reflexometer

Detailed Description:
In a blinded trial, any patient who during a game or practice situation had head contact, thus possible Traumatic Brain Injury (TBI) aka Concussion, in addition to the current approved protocols, patients are scanned with the Blink Reflexometer. Results are not available until the end of the season, thus eliminating the potential of someone relying on the results. The Blink Reflexometer uses 5 puffs of air on the side of the eye over 20 seconds. The air causes a blink reflex which is being correlated to a concussion. The results of the blink post concussion are compared to a baseline scan taken at the beginning of the season.

Layout table for study information
Study Type : Observational
Actual Enrollment : 477 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Understanding Concussion/Mild Traumatic Brain Injury
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal Volunteer
Volunteers who report to have never had a concussion and are not at high risk of getting a concussion are scanned to obtain a baseline of all ages, sex, race, etc. All patients will be scanned with the Blink Reflexometer.
Device: Blink Reflexometer
The device uses 5 light puffs of air to the side of the eye causing a blink reflex that is captured by the high-speed camera tracking the eyelids.

Concussion Protocol
Athletes who had a potential concussion and will go through any stage of the approved protocol, are scanned by the Blink Reflexometer device. Results are then analyzed prior to unblinding the clinical diagnosis from an Athletic Trainer and/or Neurologist.
Device: Blink Reflexometer
The device uses 5 light puffs of air to the side of the eye causing a blink reflex that is captured by the high-speed camera tracking the eyelids.




Primary Outcome Measures :
  1. Accuracy of Concussion Diagnosis [ Time Frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first. ]
    The results from the Blink machine should match the physicians diagnosis.


Secondary Outcome Measures :
  1. Contributing Factors [ Time Frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first. ]
    There are a number of factors that could possible change the blink reflex such as Caffeine and Tobacco. We are capturing this data to confirm that the device can be accurate despite a patient ingesting these items.

  2. Average Baseline [ Time Frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first. ]
    The goal is to eliminate the need for requiring a baseline scan on a patient in order to decide if they have a concussion or not. By scanning a large number of normal volunteers at various ages, sex, race, etc, we expect to see trends based on these factors.



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 and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.
Criteria

Inclusion Criteria:

  • Read, understand and sign patient consent (parent approval needed when pt is under 18yo)

Exclusion Criteria:

  • Diagnosed concussion in past 4 weeks
  • Ingesting any drugs banned by the US Anti-doping Association (USADA)
  • Never prior diagnosed with a neurological abnormality, including Alzheimer's, MS, Huntington's, Epilepsy, etc.

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): NCT03381638


Locations
Layout table for location information
United States, North Carolina
Johnson. C. Smith University
Charlotte, North Carolina, United States, 28216
United States, Pennsylvania
Hershey Bears Ice Hockey Team
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
The Citadel
Charleston, South Carolina, United States, 29406
South Carolina Stingrays
North Charleston, South Carolina, United States, 29418
Spartinburg High School
Spartanburg, South Carolina, United States, 29307
Sponsors and Collaborators
Blinktbi, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dena Garner, Ph.D. The Citadel

Publications of Results:
Garner, Goodwin, Tsai et al., Blink reflex parameters in baseline, active, and head-impact Division I athletes, Cogent Engineering, 2018; 5; 1429110

Other Publications:
Layout table for additonal information
Responsible Party: Blinktbi, Inc.
ClinicalTrials.gov Identifier: NCT03381638     History of Changes
Other Study ID Numbers: 1415-14d
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All patient data will be anonymized prior to dissemination. Contact the sponsor for further details.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Protocol and ICF are available any time.
Access Criteria: Case by case basis.
URL: http://www.blinktbi.com

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