HealthyNCT03975023
Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
An observational study of Healthy and Traumatic Brain Injury, run by Frederick Carrick, PhD, FACCN at 1 site in United States.
Trial summary
Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Traumatic Brain Injury
- What is being tested?
- NeuroCatch Platform (NCP)
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2019to 16 Apr 2020
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Up to 70 hockey players aged 14-25 years will be included in the study.
Who may be able to join
- Any sex, 14-25 years old inclusively
- Attending the Creative Artists Agency LLC (CAA) hockey camp in July 2019
- Able to understand the informed consent/assent form, study procedures and willing to participate in study
- NeuroCatch Platform-Specific Inclusion Criteria
- Able to remain seated and focused for 6 minutes
- Normal hearing capabilities
Who cannot join
- Unable to provide informed consent
- NeuroCatch Platform-Specific Exclusion Criteria
- Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
- In-ear hearing aid or cochlear implant, hearing device
- Implanted pacemaker or defibrillator
- Metal or plastic implants in skull
Show all 12Show fewer
- Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device during hockey camp (July 7th - 13th 2019)
- Not proficient in English
- Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
- History of seizures
- Allergy to rubbing alcohol or EEG gel
- Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Carrick Institute
Cape Cañaveral, Florida, 32920
About this study
Official title: Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity.
The present study aims to assess neurophysiological markers of auditory and visual measures of brain function using the NeuroCatch Platform and eye-tracking technology, respectively. The current gold standard of TBI evaluation, including cognitive and balance assessments, will also be captured.
- Conditions
- Healthy, Traumatic Brain Injury
- Being tested
- NeuroCatch Platform (NCP)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCatch Platform (NCP)Device
The NCP plays a proprietary 6-minute auditory stimulus sequence of tones and words that elicit involuntary evoked responses in the brain. Tone stimuli elicit N100 and P300 responses, and spoken word pairs elicit N400 responses. The NCP proprietary software identifies the latency and amplitude (timing and size) of three selected ERPs. Latency and amplitude values are reported as empirical (measured) values.
| Study group | Role | What they receive |
|---|---|---|
| hockey players | During each study visit, the participants will undergo the following procedures:
* NeuroCatch Platform (NCP) assessment (only if participant meets NCP-specific criteria)
* RightEye's eye-tracking battery
* Highmark Interactive's EQ application
* Cambridge Brain Science's neuropsychological tests Receives: Device: NeuroCatch Platform (NCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERP response size
amplitude in microvolts
Measured: 1 week
ERP response timing
latency in milliseconds
Measured: 1 week
Eye-tracking: target accuracy
distance in millimeters for each eye
Measured: 1 week
Eye-tracking: speed
degrees per second
Measured: 1 week
Secondary outcomes (2)
Cognitive tests
Cognitive assessments will be captured using Cambridge Brain Sciences battery of neuropsychological tests (composite score) and Highmark Interactive's EQ app
Measured: 1 year
Balance
Balance measured in seconds as captured by Highmark Interactive's EQ app
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start7 Jul 2019
- Primary completion11 Jul 2019
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederick Carrick, PhD, FACCN
- Sponsor type
- University, hospital or other
- Collaborators
- HealthTech Connex Inc.
- Responsible party
- Sponsor-investigator, Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975023
- Sponsor's protocol ID
- Carrick-001
- Status last verified
- Jan 2021
- First submitted
- 30 May 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
- ClinicalTrials.gov ID
- NCT03975023
- Acronym / sponsor ID
- Carrick-001
- Conditions
- Healthy, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Frederick Carrick, PhD, FACCNUniversity, hospital or other
- Collaborators
- HealthTech Connex Inc.
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 5 Jun 2019 (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.
Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity.
The present study aims to assess neurophysiological markers of auditory and visual measures of brain function using the NeuroCatch Platform and eye-tracking technology, respectively. The current gold standard of TBI evaluation, including cognitive and balance assessments, will also be captured.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hockey players | – | Device: NeuroCatch Platform (NCP)During each study visit, the participants will undergo the following procedures: * NeuroCatch Platform (NCP) assessment (only if participant meets NCP-specific criteria) * RightEye's eye-tracking battery * Highmark Interactive's EQ application * Cambridge Brain Science's neuropsychological tests |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Up to 70 hockey players aged 14-25 years will be included in the study.
Key inclusion criteria (6 listed)
- Any sex, 14-25 years old inclusively
- Attending the Creative Artists Agency LLC (CAA) hockey camp in July 2019
- Able to understand the informed consent/assent form, study procedures and willing to participate in study
- NeuroCatch Platform-Specific Inclusion Criteria
- Able to remain seated and focused for 6 minutes
Key exclusion criteria (12 listed)
- Unable to provide informed consent
- NeuroCatch Platform-Specific Exclusion Criteria
- Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
- In-ear hearing aid or cochlear implant, hearing device
- Implanted pacemaker or defibrillator
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 |
|---|---|---|
| NeuroCatch Platform (NCP)The NCP plays a proprietary 6-minute auditory stimulus sequence of tones and words that elicit involuntary evoked responses in the brain. Tone stimuli elicit N100 and P300 responses, and spoken word pairs elicit N400 responses. The NCP proprietary software identifies the latency and amplitude (timing and size) of three selected ERPs. Latency and amplitude values are reported as empirical (measured) values. | Device | hockey players |
Primary outcome
ERP response size
Time frame: 1 week
amplitude in microvolts
ERP response timing
Time frame: 1 week
latency in milliseconds
Eye-tracking: target accuracy
Time frame: 1 week
distance in millimeters for each eye
Eye-tracking: speed
Time frame: 1 week
degrees per second
2 secondary outcomes
Cognitive tests
Time frame: 1 year
Balance
Time frame: 1 week
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 27 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Traumatic Brain Injury, run by Frederick Carrick, PhD, FACCN at 1 site 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 6 inclusion and 12 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
ERP response size (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.