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

Completed

• Conditions: Healthy; Traumatic Brain Injury
• Interventions: Device: NeuroCatch Platform (NCP)

• Registration Number: NCT03975023
• Lead Sponsor: Frederick Carrick, PhD, FACCN

Brief 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.

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

Not available

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-06-01
• Study First Posted: 2019-06-05
• Study Start: 2019-07-07
• Primary Completion: 2019-07-11
• Study Completion: 2020-04-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hockey players	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Carrick Institute; 🇺🇸 Cape Cañaveral, Florida, United States