Understanding Concussion/Mild Traumatic Brain Injury

NCT03381638 | Completed DMC

• 1 other identifier: 1415-14d
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Traumatic Brain Injury; Concussion, Brain

Keywords

Concussion; TBI; Sports; Medical Device; Fast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Contributing Factors

  Data unblinded May 1, 2018 or at completion of season, which ever comes first.

• Average Baseline

  Data unblinded May 1, 2018 or at completion of season, which ever comes first.

Study Arms (2)

Normal Volunteer

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.

Device: Blink Reflexometer

Concussion Protocol

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.

Device: Blink Reflexometer

Interventions

Blink Reflexometer DEVICE

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.

Concussion Protocol; Normal Volunteer

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.

You may qualify if:

• Read, understand and sign patient consent (parent approval needed when pt is under 18yo)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blinktbi, Inc.: lead

Study Sites (5)

Johnson. C. Smith University

Charlotte, North Carolina, 28216, United States

Location

Hershey Bears Ice Hockey Team

Hershey, Pennsylvania, 17033, United States

Location

The Citadel

Charleston, South Carolina, 29406, United States

Location

South Carolina Stingrays

North Charleston, South Carolina, 29418, United States

Location

Spartinburg High School

Spartanburg, South Carolina, 29307, United States

Location

Related Publications (2)

• 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.

  PMID: 29285420 BACKGROUND

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

  RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Fasting

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Feeding Behavior; Behavior

Study Officials

• Dena Garner, Ph.D.

  The Citadel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 22, 2017
• Study Start: January 1, 2016
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Protocol and ICF are available any time.
• Access Criteria: Case by case basis.

Locations

US (5)