- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381638
Understanding Concussion/Mild Traumatic Brain Injury
April 17, 2018 updated by: Blinktbi, Inc.
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
477
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28216
- Johnson. C. Smith University
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Hershey Bears Ice Hockey Team
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South Carolina
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Charleston, South Carolina, United States, 29406
- The Citadel
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North Charleston, South Carolina, United States, 29418
- South Carolina Stingrays
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Spartanburg, South Carolina, United States, 29307
- Spartinburg High School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers with a minimum age of 14yo.
Any sex, nationality, sport played, etc are accepted.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of Concussion Diagnosis
Time Frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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The results from the Blink machine should match the physicians diagnosis.
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Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contributing Factors
Time Frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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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.
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Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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Average Baseline
Time Frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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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.
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Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dena Garner, Ph.D., The Citadel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tsai NT, Goodwin JS, Semler ME, Kothera RT, Van Horn M, Wolf BJ, Garner DP. Development of a Non-Invasive Blink Reflexometer. IEEE J Transl Eng Health Med. 2017 Dec 19;5:3800204. doi: 10.1109/JTEHM.2017.2782669. eCollection 2017.
- Garner, Goodwin, Tsai et al., Blink reflex parameters in baseline, active, and head-impact Division I athletes, Cogent Engineering, 2018; 5; 1429110
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
April 17, 2018
Study Completion (Actual)
April 17, 2018
Study Registration Dates
First Submitted
December 13, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Actual)
April 19, 2018
Last Update Submitted That Met QC Criteria
April 17, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1415-14d
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All patient data will be anonymized prior to dissemination.
Contact the sponsor for further details.
IPD Sharing Time Frame
Protocol and ICF are available any time.
IPD Sharing Access Criteria
Case by case basis.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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