The Effects of Subconcussive Events on Cognition

Cerebral Injury Clinical Trial

Official title:

The Effects of Subconcussive Events on Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394248
• Other study ID #: BHS-1304
• Status: Completed
• Start date: January 26, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2022
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 13, 2020
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Injury

Intervention

Device:
• Vector Mouthguard
The mouthguard will be used by athletes to measure the magnitude and number of impacts throughout one season.

Locations

Country	Name	City	State
United States	New York Institute of Technology	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	King-Devick Test	Objectively measures visual tracking and saccadic eye movements	5 months
Secondary	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