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
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 Type :||Observational|
|Estimated Enrollment :||70 participants|
|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|
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.
- 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
- 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
- Trends between outcome measures and demographics will be explored [ Time Frame: 1 year ]Demographics include age, concussion history, and handedness
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
|United States, Florida|
|The Carrick Institute||Recruiting|
|Cape Cañaveral, Florida, United States, 32920|
|Contact: Carrick 321-868-6464 firstname.lastname@example.org|