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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975023
• Other study ID #: Carrick-001
• Status: Completed
• Start date: July 7, 2019
• Est. completion date: April 16, 2020

Study information

• Verified date: January 2021
• Source: Carrick Institute for Graduate Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 16, 2020
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Healthy
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	The Carrick Institute	Cape Cañaveral	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Frederick Carrick, PhD, FACCN	HealthTech Connex Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trends between outcome measures and demographics will be explored	Demographics include age, concussion history, and handedness	1 year
Primary	ERP response size	amplitude in microvolts	1 week
Primary	ERP response timing	latency in milliseconds	1 week
Primary	Eye-tracking: target accuracy	distance in millimeters for each eye	1 week
Primary	Eye-tracking: speed	degrees per second	1 week
Secondary	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
Secondary	Balance	Balance measured in seconds as captured by Highmark Interactive's EQ app	1 week