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

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ClinicalTrials.gov Identifier: NCT03515967
Recruitment Status : Withdrawn (Study closed.)
First Posted : May 4, 2018
Last Update Posted : April 15, 2019
Sponsor:
Collaborators:
Syneos Health
Neuro Kinetics
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 4, 2018
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE March 19, 2018
Actual Primary Completion Date April 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
Number of participants with mTBI [ Time Frame: 45 months ]
How many participants were detected to have mTBI following a sports-related injury
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03515967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
Time to recover [ Time Frame: 45 months ]
Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Injuries, Traumatic
Intervention  ICMJE Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
Study Arms  ICMJE
  • Experimental: Injured Athletes
    Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles
    Intervention: Device: I-PAS Goggles
  • Active Comparator: Non-Injured Athletes
    Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles
    Intervention: Device: I-PAS Goggles
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 11, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2018)
1000
Actual Study Completion Date  ICMJE April 8, 2019
Actual Primary Completion Date April 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515967
Other Study ID Numbers  ICMJE 20170209
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael E. Hoffer, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • Syneos Health
  • Neuro Kinetics
Investigators  ICMJE
Principal Investigator: Michael Hoffer, MD University of Miami
PRS Account University of Miami
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP