Concussion Testing: A Novel Non-invasive Concussion Detection Device
NCT ID: NCT02370914
Last Updated: 2022-08-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
84 participants
OBSERVATIONAL
2011-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Suspected Concussive Event (SCE)
When a subject is suspected of a concussion, a Nautilus NeuroWaveTM System recording is obtained from the subject and the recording is evaluated by a Jan Medical concussion algorithm. The subject is declared concussed or not per the algorithm. This is compared to a Sport Concussion Assessment Tool (SCAT) test.
Nautilus NeuroWaveTM System
Recording of subjects with Nautilus NeuroWave diagnostic device
SCAT
A Neurocognitive evaluation of the patients to assess for concussion.
Control
All subjects at the start of study have a baseline recording using the Nautilus NeuroWaveTM System. These subjects are enrolled into the study as non-concussed and these recordings serve as control recordings. Additionally, some subjects from this cohort will be recorded again at the end of the study to obtain end of season recordings. These results are compared to a Sport Concussion Assessment Tool (SCAT) test.
Nautilus NeuroWaveTM System
Recording of subjects with Nautilus NeuroWave diagnostic device
SCAT
A Neurocognitive evaluation of the patients to assess for concussion.
Interventions
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Nautilus NeuroWaveTM System
Recording of subjects with Nautilus NeuroWave diagnostic device
SCAT
A Neurocognitive evaluation of the patients to assess for concussion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
18 Years
MALE
Yes
Sponsors
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Jan Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul S Auerbach
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Los Altos High School
Los Altos, California, United States
Countries
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Other Identifiers
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21114
Identifier Type: -
Identifier Source: org_study_id
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