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Completed

NCT Number: NCT03975023

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.

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Key information

Conditions

Healthy Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Carrick Institute

Cape Cañaveral, Florida, 32920, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. ERP response size

    Time frame: 1 week

    amplitude in microvolts

  2. ERP response timing

    Time frame: 1 week

    latency in milliseconds

  3. Eye-tracking: target accuracy

    Time frame: 1 week

    distance in millimeters for each eye

  4. Eye-tracking: speed

    Time frame: 1 week

    degrees per second

Secondary outcomes

  1. Cognitive tests

    Time frame: 1 year

    Cognitive assessments will be captured using Cambridge Brain Sciences battery of neuropsychological tests (composite score) and Highmark Interactive's EQ app

  2. Balance

    Time frame: 1 week

    Balance measured in seconds as captured by Highmark Interactive's EQ app

Other outcomes

  1. Trends between outcome measures and demographics will be explored

    Time frame: 1 year

    Demographics include age, concussion history, and handedness

Sponsors and collaborators

Lead sponsor

Frederick Carrick, PhD, FACCN

Other

Collaborators

  • HealthTech Connex Inc.

Registry information

Official study title

Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 5, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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