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Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.
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| Name | Affiliation | Role |
|---|---|---|
| Dena Garner, Ph.D. | The Citadel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson. C. Smith University | Charlotte | North Carolina | 28216 | United States | ||
| Hershey Bears Ice Hockey Team |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29285420 | Background | 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. | |
| Result | Garner, Goodwin, Tsai et al., Blink reflex parameters in baseline, active, and head-impact Division I athletes, Cogent Engineering, 2018; 5; 1429110 |
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All patient data will be anonymized prior to dissemination. Contact the sponsor for further details.
Protocol and ICF are available any time.
Case by case basis.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| The Citadel | Charleston | South Carolina | 29406 | United States |
| South Carolina Stingrays | North Charleston | South Carolina | 29418 | United States |
| Spartinburg High School | Spartanburg | South Carolina | 29307 | United States |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D005247 | Feeding Behavior |
| D001519 | Behavior |