Understanding Concussion/Mild Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Understanding Concussion/Mild Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381638
• Other study ID #: 1415-14d
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Traumatic Brain Injury
• Wounds and Injuries

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.