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Withdrawn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
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Sponsor:
University of Miami
Collaborators:
Syneos Health
Neuro Kinetics
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami
Tracking Information | |||||||||||
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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 |
Number of participants with mTBI [ Time Frame: 45 months ] How many participants were detected to have mTBI following a sports-related injury
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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 |
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
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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 |
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Condition ICMJE | Brain Injuries, Traumatic | ||||||||||
Intervention ICMJE | Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Withdrawn | ||||||||||
Actual Enrollment ICMJE |
0 | ||||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Michael E. Hoffer, University of Miami | ||||||||||
Study Sponsor ICMJE | University of Miami | ||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |