An observational study in Cerebral Injury, sponsored by New York Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by New York Institute of Technology · Observational
The purpose of this study is to determine early detection of concussion for those at risk of developing symptoms and to be able to detect subconcussive cerebral impairment, and thus gaining a better understanding of the injury patterns for concussions in Men's and Women's Collegiate sports.
Description of the Research Subjects will be members of NYIT's Collegiate Athletic Teams. Potential subjects will be informed about the proposed study and asked if the athlete is interested in participating. If the athlete agrees, the key investigator will review the study procedures, what is expected of the subject, and complete the informed consent process. Participation will be completely voluntary and will have no impact on the quality of care the subject will receive. Inclusion and exclusion criteria will then be evaluated by the key investigator to determine if the subject is qualified to participate in this study. Following consent and review of inclusion and exclusion criteria, the subject will be assigned a subject identification number in which is intended to maintain confidentiality of the subject's personal health information. The number will be used for the duration of the study and in all analyses. Once enrolled, the subjects will complete a baseline questionnaire* that will include demographic information and personal history, as well as consent for de-identified information to be shared with a third party, Quadrant Biosciences, for research purposes. The subjects will be evaluated by a series of measurements, ClearEdge, Quadrant Bioscience Salivary Testing, King Devick, and Im PACT, in the preseason, midseason, and postseason, or if they are suspected of a concussion by the athletic trainer or team physician. Visit 1: Baseline Data Collection
Subjects for this study will be members of the NYIT Athletic Teams.
Exclusion Criteria:
The subject suffered from any of the following at the time of event leading to a concussion:
The mouthguard will be used by athletes to measure the magnitude and number of impacts throughout one season.
Changes in cognition secondary to impact
A mouthguard with built in sensors to collect data above the predetermined acceleration thresholds. The predetermined threshold for acceleration will be set to 5G in order to collect more data about subconcussive impacts, in addition to concussive impacts
Time frame: 5 months
ImPACT Testing
Tool to help detect and assess the severity of concussion in athletes by establishing a baseline of memory and cognitive function
Time frame: 5 months
King-Devick Test
Objectively measures visual tracking and saccadic eye movements
Time frame: 5 months
C3 Logix
Concussion Assessment application with the ability to track a patient's dynamic vision reflexes and ability to focus on moving objects
Time frame: 5 months
Plan to share: Undecided — May share with osteopathic medical research students
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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New York Institute of Technology