A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion

Study Overview
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Brief Summary
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The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.

Detailed Description
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This is a prospective, non-randomized, blinded, matched control study of young athletes (ages 10-25 years old) in competitive sports (Cohort A: higher-risk of concussion, Cohort B: lower-risk of concussion) to assess the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion. The Nautilus BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the brain pulse, the brain motion caused by pulsatile blood flow from the cardiac cycle. The Nautilus BrainPulse analyzes the captured data to provide an aid in diagnosing an episode of concussion.

Official Title
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A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion

Conditions
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Concussion

Intervention / Treatment
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* Device: Nautilus BrainPulse Recording


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects between 10 and 25 years of age (middle school, high school or college-age) Team member, where the team meets at least twice a week Willing and able to participate in all study evaluations and allow access to medical testing and records Signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor Exclusion Criteria: Documented history of a concussion diagnosed by a physician in the last two months assessed via interview with athlete Known history of any cognitive deficits that diminish ability to administer study assessments, such as SCAT3™ Wound on the head in the area of one of the Nautilus BrainPulse sensors that would impede use of the Nautilus BrainPulse device Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion Any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A: High-Risk of Concussion<br>Middle school, high school and college athletes of either gender participating in sports where high-risk of concussion is anticipated: football, soccer, lacrosse, hockey, basketball, ice hockey, field hockey, rugby, cheerleading, boxing, and gymnastics. | Device: Nautilus BrainPulse Recording<br>* Comparison of Nautilus BrainPulse recordings in subjects who have a concussive event (Cohort A) to Nautilus BrainPulse recording in subjects who do not experience a concussive events (Cohort B or matched subjects to Cohort A). Recordings are obtained over a 2 week period every 2 to 3 days (at least 5 recordings per subject).<br>|
| Cohort B: Low-Risk of Concussion<br>Middle school, high school and college athletes of either gender participating in sports where low-risk of concussion is anticipated: swimming, track, volleyball, baseball, softball and golf. | Device: Nautilus BrainPulse Recording<br>* Comparison of Nautilus BrainPulse recordings in subjects who have a concussive event (Cohort A) to Nautilus BrainPulse recording in subjects who do not experience a concussive events (Cohort B or matched subjects to Cohort A). Recordings are obtained over a 2 week period every 2 to 3 days (at least 5 recordings per subject).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the Nautilus Brain Pulse in detecting concussion as compared to adjudication by a panel of medical experts | Sensitivity and Specificity of the Nautilus BrainPulse in detecting the number of subjects experiencing concussion as compared to the number of subjects with concussion as adjudicated by a panel of medical experts. BrainPulse measurement data will be aggregated by subject over the first 10-days of recording after the concussive event, or for subjects in the Control arm, after their selection as a control subject. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion