Control Study of Nautilus BrainPulse for the Detection of Concussion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

Brief Summary

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To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.

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Detailed Description

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This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.

The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.

Conditions

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Brain Concussion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Nautilus BrainPulse

Intervention Type DEVICE

A noninvasive device to detect concussion utilizing headset and sensors

Interventions

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Nautilus BrainPulse

A noninvasive device to detect concussion utilizing headset and sensors

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female between 14 and 19 years of age
* Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
* Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf

Exclusion Criteria

* History, if any, of concussion or stroke
* History, if any, of alcohol or drug abuse
* History, if any, of mental disorder or cerebrovascular disorder
* Pregnant women
* Failure to comply with recording schedule
* Not suitable for participation in the study in the opinion of the PI
* Have suffered a concussion during the study
* Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country)
* Related to a Jan Medical employee

Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes