The Effects of Subconcussive Events on Cognition

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Injury
• Intervention / Treatment: Device: Vector Mouthguard

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • New York Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects for this study will be members of the NYIT Athletic Teams.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ImPACT Testing	Tool to help detect and assess the severity of concussion in athletes by establishing a baseline of memory and cognitive function	5 months
King-Devick Test	Objectively measures visual tracking and saccadic eye movements	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	5 months

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Principal Investigator: Matthew Heller, D.O, New York Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Subconcussive head injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: BHS-1304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: May share with osteopathic medical research students

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No