Clinical trial NCT03381638: Understanding Concussion/Mild Traumatic Brain Injury
Official title: Understanding Concussion/Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Concussion, Brain
Keywords: Concussion
TBI
Sports
Medical Device
Fast
Lead sponsor: Blinktbi, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-22
Enrollment: 477
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.

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.

Eligibility 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.

Primary outcomes:
measure: Accuracy of Concussion Diagnosis
timeFrame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Secondary outcomes:
measure: Contributing Factors
timeFrame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
measure: Average Baseline
timeFrame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Johnson. C. Smith University
state: North Carolina
city: Hershey
country: United States
facility: Hershey Bears Ice Hockey Team
state: Pennsylvania
city: Charleston
country: United States
facility: The Citadel
state: South Carolina
city: North Charleston
country: United States
facility: South Carolina Stingrays
state: South Carolina
city: Spartanburg
country: United States
facility: Spartinburg High School
state: South Carolina
Study officials:
affiliation: The Citadel
name: Dena Garner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Garner, Goodwin, Tsai et al., Blink reflex parameters in baseline, active, and head-impact Division I athletes, Cogent Engineering, 2018; 5; 1429110