Clinical trial NCT03394248: The Effects of Subconcussive Events on Cognition
Official title: The Effects of Subconcussive Events on Cognition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Injury
Keywords: Subconcussive head injury
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects for this study will be members of the NYIT Athletic Teams.

Brief summary: 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.

Detailed description: 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

* Assessment Tools
* Demographic/Baseline questionnaire\*
* ImPACT
* King-Devick
* ClearEdge New York Institute of Technology Institutional Review Board Approved From 07/18/20 to 07/17/21
* Quadrant Bioscience Salivary Testing
* Quadrant Bioscience Salivary Testing Questionnaire
* Estimated Time: 1.5 hours Visit 2: Mid-Season Collection
* Assessment Tools
* ImPACT
* King-Devick
* ClearEdge
* Quadrant Bioscience Salivary Testing
* Quadrant Bioscience Salivary Testing Questionnaire
* Estimated time: 1 hour Visit 3: Post-season Data Collection
* Assessment Tools
* ImPACT
* King-Devick
* ClearEdge
* Quadrant Bioscience Salivary Testing
* Quadrant Bioscience Salivary Testing Questionnaire
* Estimated time: 1 hr Visit 4: If athlete is suspected to have sustained a concussion by the athletic trainer or team physician, the athlete will come for an additional visit
* Assessment Tools
* ImPACT
* King-Devick
* ClearEdge
* Quadrant Bioscience Salivary Testing
* Quadrant Bioscience Salivary Testing Questionnaire
* Estimated time: 1 hr

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years age and younger than 50 years of age
* Subject experiences at least 8Gs of force on at least one occasion, as measured by accelerometer

Exclusion Criteria:

* The subject suffered from any of the following at the time of event leading to a concussion:

  * Loss of consciousness \>2 minutes in the field as reported by witness
  * Seizures
  * Intractable vomiting
  * Paralysis
* The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g. Parkinson's Disease, Alzheimer's Disease)
* The subject has a current or previous spinal cord injury
* The subject is unable to complete assessment tools
* The subject is pregnant

Primary outcomes:
measure: Changes in cognition secondary to impact
timeFrame: 5 months
Secondary outcomes:
measure: ImPACT Testing
timeFrame: 5 months
measure: King-Devick Test
timeFrame: 5 months
measure: C3 Logix
timeFrame: 5 months
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Matthew Heller, D.O
role: PRINCIPAL_INVESTIGATOR
References: