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

NCT03975023 | Completed FDA Device

• 1 other identifier: Carrick-001
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Cognitive tests

  1 year

• Balance

  1 week

Other Outcomes (1)

• Trends between outcome measures and demographics will be explored

  1 year

Study Arms (1)

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)

Interventions

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.

hockey players

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Frederick Carrick, PhD, FACCN: lead
• HealthTech Connex Inc.: collaborator

Study Sites (1)

The Carrick Institute

Cape Cañaveral, Florida, 32920, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Frederick R Carrick

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: July 7, 2019
• Primary Completion: July 11, 2019
• Study Completion: April 16, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)