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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Traumatic Brain Injury
• Intervention / Treatment: Device: NeuroCatch Platform (NCP)

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Cañaveral, Florida, United States, 32920
      • The Carrick Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Up to 70 hockey players aged 14-25 years will be included in the study.

Description

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

NeuroCatch Platform-Specific Inclusion Criteria

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

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ERP response size	amplitude in microvolts	1 week
ERP response timing	latency in milliseconds	1 week
Eye-tracking: target accuracy	distance in millimeters for each eye	1 week
Eye-tracking: speed	degrees per second	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive tests	Cognitive assessments will be captured using Cambridge Brain Sciences battery of neuropsychological tests (composite score) and Highmark Interactive's EQ app	1 year
Balance	Balance measured in seconds as captured by Highmark Interactive's EQ app	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trends between outcome measures and demographics will be explored	Demographics include age, concussion history, and handedness	1 year

Collaborators and Investigators

• Sponsor: Frederick Carrick, PhD, FACCN
• Collaborators: HealthTech Connex Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2019
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 1, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Carrick-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No