Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players

NCT ID: NCT03975023

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-07

Study Completion Date

2020-04-16

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

NeuroCatch Platform (NCP)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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


* Able to remain seated and focused for 6 minutes
* Normal hearing capabilities

Exclusion Criteria

• Unable to provide informed consent


* 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
* 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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HealthTech Connex Inc.

INDUSTRY

Sponsor Role collaborator

Frederick Carrick, PhD, FACCN

OTHER

Sponsor Role lead

Responsible Party

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Frederick Carrick, PhD, FACCN

Prof Frederick R Carrick

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Carrick Institute

Cape Cañaveral, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Carrick-001

Identifier Type: -

Identifier Source: org_study_id

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