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出境医 / 临床实验 / Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Study Description
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) |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 52 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 |
| Actual Primary Completion Date : | July 11, 2019 |
| Actual Study Completion Date : | April 16, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
hockey players
During each study visit, the participants will undergo the following procedures:
|
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.
|
Outcome Measures
Primary Outcome Measures :
- ERP response size [ Time Frame: 1 week ]amplitude in microvolts
- ERP response timing [ Time Frame: 1 week ]latency in milliseconds
- Eye-tracking: target accuracy [ Time Frame: 1 week ]distance in millimeters for each eye
- Eye-tracking: speed [ Time Frame: 1 week ]degrees per second
Secondary Outcome Measures :
- 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
- Balance [ Time Frame: 1 week ]Balance measured in seconds as captured by Highmark Interactive's EQ app
Other Outcome Measures:
- Trends between outcome measures and demographics will be explored [ Time Frame: 1 year ]Demographics include age, concussion history, and handedness
Eligibility Criteria
| 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)
Contacts and Locations
Locations
| United States, Florida | |
| The Carrick Institute | |
| Cape Cañaveral, Florida, United States, 32920 | |
Sponsors and Collaborators
Frederick Carrick, PhD, FACCN
HealthTech Connex Inc.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 30, 2019 | ||||||||
| First Posted Date | June 5, 2019 | ||||||||
| Last Update Posted Date | January 27, 2021 | ||||||||
| Actual Study Start Date | July 7, 2019 | ||||||||
| Actual Primary Completion Date | July 11, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Trends between outcome measures and demographics will be explored [ Time Frame: 1 year ] Demographics include age, concussion history, and handedness
|
||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players | ||||||||
| Official Title | Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Up to 70 hockey players aged 14-25 years will be included in the study. | ||||||||
| Condition |
|
||||||||
| 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.
|
||||||||
| Study Groups/Cohorts | hockey players
During each study visit, the participants will undergo the following procedures:
Intervention: Device: NeuroCatch Platform (NCP)
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Completed | ||||||||
| Actual Enrollment |
52 | ||||||||
| Original Estimated Enrollment |
70 | ||||||||
| Actual Study Completion Date | April 16, 2020 | ||||||||
| Actual Primary Completion Date | July 11, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
NeuroCatch Platform-Specific Inclusion Criteria
Exclusion Criteria: • Unable to provide informed consent NeuroCatch Platform-Specific Exclusion Criteria
|
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| Sex/Gender |
|
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| Ages | 14 Years to 25 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03975023 | ||||||||
| Other Study ID Numbers | Carrick-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies | ||||||||
| Study Sponsor | Frederick Carrick, PhD, FACCN | ||||||||
| Collaborators | HealthTech Connex Inc. | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Carrick Institute for Graduate Studies | ||||||||
| Verification Date | January 2021 | ||||||||
