Traumatic Brain InjuryNCT03381638
Understanding Concussion/Mild Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Concussion, Brain, run by Blinktbi, Inc. at 5 sites in United States.
Trial summary
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Concussion, Brain
- What is being tested?
- Blink Reflexometer
- Type of treatment
- Medical device
- How many people
- 477 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2016to 17 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.
Who may be able to join
- Read, understand and sign patient consent (parent approval needed when pt is under 18yo)
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Citadel
Charleston, South Carolina, 29406
Johnson. C. Smith University
Charlotte, North Carolina, 28216
Hershey Bears Ice Hockey Team
Hershey, Pennsylvania, 17033
South Carolina Stingrays
North Charleston, South Carolina, 29418
Spartinburg High School
Spartanburg, South Carolina, 29307
About this study
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
Read the 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.
- Conditions
- Traumatic Brain Injury, Concussion, Brain
- Being tested
- Blink Reflexometer
- Keywords
- Concussion, TBI, Sports, Medical Device, Fast
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blink ReflexometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Blink Reflexometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Concussion Diagnosis
The results from the Blink machine should match the physicians diagnosis.
Measured: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Secondary outcomes (2)
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.
Measured: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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.
Measured: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Jan 2016
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blinktbi, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dena Garner, Ph.D., Principal investigator, The Citadel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381638
- Sponsor's protocol ID
- 1415-14d
- Status last verified
- Apr 2018
- First submitted
- 13 Dec 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient data will be anonymized prior to dissemination. Contact the sponsor for further details.
Publications
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.
PubMed 29285420Garner, Goodwin, Tsai et al., Blink reflex parameters in baseline, active, and head-impact Division I athletes, Cogent Engineering, 2018; 5; 1429110
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Concussion/Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03381638
- Acronym / sponsor ID
- 1415-14d
- Conditions
- Traumatic Brain Injury, Concussion, Brain
- Keywords
- Concussion, TBI, Sports, Medical Device, Fast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Blinktbi, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Volunteer | – | Device: Blink ReflexometerVolunteers 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 | – | Device: Blink ReflexometerAthletes 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.
Key inclusion criteria (1 listed)
- Read, understand and sign patient consent (parent approval needed when pt is under 18yo)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blink ReflexometerThe 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. | Device | Concussion Protocol, Normal Volunteer |
Primary outcome
Accuracy of Concussion Diagnosis
Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
The results from the Blink machine should match the physicians diagnosis.
2 secondary outcomes
Contributing Factors
Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Average Baseline
Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 29285420Tsai 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.
- Results publicationGarner, Goodwin, Tsai et al., Blink reflex parameters in baseline, active, and head-impact Division I athletes, Cogent Engineering, 2018; 5; 1429110
- Individual participant dataSharing planned: Yes. All patient data will be anonymized prior to dissemination. Contact the sponsor for further details.
Related trials for Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Not yet recruitingObservational study
Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)
Diffusion Tensor Imaging Prognosis, Brain Injury, Traumatic
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dena Garner, Ph.D. principal investigator
The Citadel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Concussion, Brain, run by Blinktbi, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Concussion Diagnosis (time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381638, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.