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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03381638
Other study ID # 1415-14d
Secondary ID
Status Completed
Phase
First received December 13, 2017
Last updated April 17, 2018
Start date January 1, 2016
Est. completion date April 17, 2018

Study information

Verified date April 2018
Source Blinktbi, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 477
Est. completion date April 17, 2018
Est. primary completion date April 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
United States The Citadel Charleston South Carolina
United States 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

Sponsors (1)

Lead Sponsor Collaborator
Blinktbi, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of Concussion Diagnosis The results from the Blink machine should match the physicians diagnosis. Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Secondary Contributing Factors 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. Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Secondary Average Baseline 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. Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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