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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: High-Risk of Concussion | 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. |
| |
| Cohort B: Low-Risk of Concussion | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nautilus BrainPulse Recording | Device | 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort A: High-Risk of Concussion 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.
Cohort B: Low-Risk of Concussion 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.
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| Name | Affiliation | Role |
|---|---|---|
| Gary Abrams, MD, | University of California San Francisco Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meli Orthopedic Centers of Excellence | Fort Lauderdale | Florida | 33308 | United States | ||
| Community Hospital |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Munster |
| Indiana |
| 46321 |
| United States |
| Louisiana State University | Baton Rouge | Louisiana | 70803 | United States |
| University of Wyoming | Laramie | Wyoming | 82070 | United States |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |