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Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups

Primary Purpose

Brain Injuries, Traumatic

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-PAS Goggles
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries, Traumatic focused on measuring concussion, mild traumatic brain injury

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).
  2. Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
  3. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby.

Exclusion Criteria:

  1. History of brain injury resulting from a penetrating wound to the head.
  2. Presence of aphasia and/or inability to give informed consent for participation
  3. History of diagnosed neuropsychiatric disorders
  4. Documented neurodegenerative disorders

  5. Prior disorders of hearing and balance including:

    1. Meniere's disease
    2. Multiple sclerosis
    3. Vestibular neuritis
    4. Vestibular schwannoma
    5. Sudden sensorineural hearing loss
  6. Cerebrovascular disorders
  7. History of ear operation other than myringotomy tube in the past
  8. Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
  9. Presence of intra-cranial structural findings on imaging studies
  10. Prisoners

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Injured Athletes

    Non-Injured Athletes

    Arm Description

    Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles

    Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles

    Outcomes

    Primary Outcome Measures

    Number of participants with mTBI
    How many participants were detected to have mTBI following a sports-related injury

    Secondary Outcome Measures

    Time to recover
    Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI

    Full Information

    First Posted
    April 23, 2018
    Last Updated
    June 24, 2020
    Sponsor
    University of Miami
    Collaborators
    Syneos Health, Neurolign
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03515967
    Brief Title
    Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups
    Official Title
    The Use of a Portable 3D Head Mounted Display With Integrated Eye Capture Technology (I-PAS) for the Objectification and Quantification of Signs and Symptoms Associated With the Diagnosis of Mild Traumatic Brain Injury (mTBI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Inability to recruit
    Study Start Date
    March 19, 2018 (Actual)
    Primary Completion Date
    April 8, 2019 (Actual)
    Study Completion Date
    April 8, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami
    Collaborators
    Syneos Health, Neurolign

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries, Traumatic
    Keywords
    concussion, mild traumatic brain injury

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Injured Athletes
    Arm Type
    Experimental
    Arm Description
    Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles
    Arm Title
    Non-Injured Athletes
    Arm Type
    Active Comparator
    Arm Description
    Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles
    Intervention Type
    Device
    Intervention Name(s)
    I-PAS Goggles
    Intervention Description
    Portable, head-mounted display goggle system with integrated eye capture technology
    Primary Outcome Measure Information:
    Title
    Number of participants with mTBI
    Description
    How many participants were detected to have mTBI following a sports-related injury
    Time Frame
    45 months
    Secondary Outcome Measure Information:
    Title
    Time to recover
    Description
    Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI
    Time Frame
    45 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey). Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby. Exclusion Criteria: History of brain injury resulting from a penetrating wound to the head. Presence of aphasia and/or inability to give informed consent for participation History of diagnosed neuropsychiatric disorders Documented neurodegenerative disorders Prior disorders of hearing and balance including: Meniere's disease Multiple sclerosis Vestibular neuritis Vestibular schwannoma Sudden sensorineural hearing loss Cerebrovascular disorders History of ear operation other than myringotomy tube in the past Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc. Presence of intra-cranial structural findings on imaging studies Prisoners
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Hoffer, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28894835
    Citation
    Hoffer ME, Balaban C, Szczupak M, Buskirk J, Snapp H, Crawford J, Wise S, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. The use of oculomotor, vestibular, and reaction time tests to assess mild traumatic brain injury (mTBI) over time. Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):157-165. doi: 10.1002/lio2.74. eCollection 2017 Aug.
    Results Reference
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    PubMed Identifier
    27654131
    Citation
    Balaban C, Hoffer ME, Szczupak M, Snapp H, Crawford J, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury. PLoS One. 2016 Sep 21;11(9):e0162168. doi: 10.1371/journal.pone.0162168. eCollection 2016.
    Results Reference
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    Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups

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