Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03975023
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
HealthTech Connex Inc.
Information provided by (Responsible Party):
Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies

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.


Condition or disease Intervention/treatment
Healthy Traumatic Brain Injury Device: NeuroCatch Platform (NCP)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Actual Study Start Date : July 7, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Trends between outcome measures and demographics will be explored [ Time Frame: 1 year ]
    Demographics include age, concussion history, and handedness



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Up to 70 hockey players aged 14-25 years will be included in the study.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975023


Contacts
Layout table for location contacts
Contact: Carrick 1-321-868-6464 drfrcarrick@post.harvard.edu

Locations
Layout table for location information
United States, Florida
The Carrick Institute Recruiting
Cape Cañaveral, Florida, United States, 32920
Contact: Carrick    321-868-6464    drfrcarrick@post.harvard.edu   
Sponsors and Collaborators
Frederick Carrick, PhD, FACCN
HealthTech Connex Inc.

Layout table for additonal information
Responsible Party: Frederick Carrick, PhD, FACCN, Prof Frederick R Carrick, Carrick Institute for Graduate Studies
ClinicalTrials.gov Identifier: NCT03975023     History of Changes
Other Study ID Numbers: Carrick-001
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries