Understanding Concussion/Mild Traumatic Brain Injury

Blinktbi

Status: Completed

Conditions: Traumatic Brain Injury; Concussion, Brain

Treatments: Device: Blink Reflexometer

Study type: Observational

Funder types: Industry

Identifiers

NCT03381638

1415-14d

Details and patient eligibility

About

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

Full 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.

Enrollment: 477 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

477 participants in 2 patient groups

Normal Volunteer

Description:

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.

Treatment:

Device: Blink Reflexometer

Concussion Protocol

Description:

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.

Treatment:

Device: Blink Reflexometer