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The Effects of Subconcussive Events on Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394248
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Heller, New York Institute of Technology

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.

Condition or disease Intervention/treatment
Cerebral Injury Device: Vector Mouthguard

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Study Type : Observational [Patient Registry]
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Effects of Subconcussive Events on Cognition
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : July 3, 2018
Estimated Study Completion Date : June 20, 2019

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


Primary Outcome Measures :
  1. Changes in cognition secondary to impact [ Time Frame: 5 months ]
    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


Secondary Outcome Measures :
  1. ImPACT Testing [ Time Frame: 5 months ]
    Tool to help detect and assess the severity of concussion in athletes by establishing a baseline of memory and cognitive function

  2. King-Devick Test [ Time Frame: 5 months ]
    Objectively measures visual tracking and saccadic eye movements

  3. C3 Logix [ Time Frame: 5 months ]
    Concussion Assessment application with the ability to track a patient's dynamic vision reflexes and ability to focus on moving objects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects for this study will be members of the NYIT Athletic Teams.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394248


Locations
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United States, New York
New York Institute of Technology
Old Westbury, New York, United States, 11568
Sponsors and Collaborators
New York Institute of Technology
Additional Information:

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Responsible Party: Matthew Heller, Assistant Professor, Family Medicine, New York Institute of Technology
ClinicalTrials.gov Identifier: NCT03394248    
Other Study ID Numbers: BHS-1304
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: May share with osteopathic medical research students

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Heller, New York Institute of Technology:
Subconcussive head injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries