Understanding Concussion/Mild Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury; Concussion, Brain
• Interventions: Device: Blink Reflexometer

• Registration Number: NCT03381638
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Status Verified: 2018-04
• Primary Completion: 2018-04-17
• Study Completion: 2018-04-17
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Volunteer	Blink Reflexometer	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.
Concussion Protocol	Blink Reflexometer	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of Concussion Diagnosis	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

Name	Time	Method
Contributing Factors	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.
Average Baseline	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.

Trial Locations

Locations (5)

Johnson. C. Smith University; 🇺🇸 Charlotte, North Carolina, United States

Hershey Bears Ice Hockey Team; 🇺🇸 Hershey, Pennsylvania, United States

South Carolina Stingrays; 🇺🇸 North Charleston, South Carolina, United States

Spartinburg High School; 🇺🇸 Spartanburg, South Carolina, United States

The Citadel; 🇺🇸 Charleston, South Carolina, United States