The Effects of Subconcussive Events on Cognition
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2018
CompletedStudy Start
First participant enrolled
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedApril 14, 2022
April 1, 2022
5 months
December 20, 2017
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
ImPACT Testing
5 months
King-Devick Test
5 months
C3 Logix
5 months
Interventions
The mouthguard will be used by athletes to measure the magnitude and number of impacts throughout one season.
Eligibility Criteria
Subjects for this study will be members of the NYIT Athletic Teams.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Institute of Technology
Old Westbury, New York, 11568, United States
Biospecimen
Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Heller, D.O
New York Institute of Technology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Family Medicine
Study Record Dates
First Submitted
December 20, 2017
First Posted
January 9, 2018
Study Start
January 26, 2018
Primary Completion
July 3, 2018
Study Completion
March 13, 2020
Last Updated
April 14, 2022
Record last verified: 2022-04