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The purpose of this study is to establish and evaluate a distinctive signal for concussion.
The purpose of this study is to establish a non-invasive objective measurement for the detection of concussions with the Jan Medical Device (JMD). The study will assess the ability of this device to demonstrate unique signals that correlate with concussions. The study will also test the athletes at baseline at rest and during exertion to determine if there is a difference in the signal from exertion alone. The JMD is a non-invasive band that is placed around the participants head. The JMD detects a unique pattern of signals based on displacement of the skull from changes in blood flow during individual heartbeats. The athletes will be tested longitudinally to assess to changes over time, in addition to changes after impact
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nautilus NeuroWaveTM System | Device | Recording of subjects with Nautilus NeuroWave diagnostic device |
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| Measure | Description | Time Frame |
|---|---|---|
| A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data | Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise. | Individual assessments were made within 2 days of recording |
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Inclusion Criteria:
Exclusion Criteria:
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Varsity high school football players at a local High School.
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| Name | Affiliation | Role |
|---|---|---|
| Paul S Auerbach | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Altos High School | Los Altos | California | 94022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic Device - Nautilus NeuroWave | Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic Device - Nautilus NeuroWave | Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data | Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise. | Analysis population includes all participants. Some of these participants were were declared concussed by the physician in the team during the course of the season. All baseline recordings were treated as from non-concussed participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Individual assessments were made within 2 days of recording |
assessed from enrollment (baseline recording at beginning of sports season) to end of follow-up (end of sports season at 5 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic Device - Nautilus NeuroWave | Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device |
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This is a pilot study only. Only 15 concussions were observed from a single gender teenage population from one high school football team over one season. Further data from a broader population is needed to confirm results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Auerbach | Stanford University | (650) 725-9445 | auerbach@stanford.edu |
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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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| SCAT | Behavioral | A Neurocognitive evaluation of the patients to assess for concussion. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Sport Concussion Assessment Tool- Second Edition (SCAT 2) | SCAT2 was used to perform baseline testing in athletes before the football season began. Of these, 9 without a concussion during the season, elected to have another recording done at the end of the year. If an athlete sustained an impact and sideline physicians or trainers regarded the impact as a concussion, the athlete had a SCAT2 test performed and Jan Medical Device (JMD) testing.The scale is based on total symptoms and symptom severity score, with 0 being least severe and 132 being most severe. In other words, the higher the the score value, the worse the condition. Score range is 0-132. | Mean | Standard Deviation | units on a scale |
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| 0 |
| 82 |
| 0 |
| 82 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |