An observational study in Concussion, sponsored by Jan Medical, Inc.. Completed at 1 site in United States. Open to male participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Jan Medical, Inc. · Observational
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
Jan Medical, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Varsity high school football players at a local High School.
Exclusion Criteria:
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.
Device: Nautilus NeuroWaveTM System · Behavioral: SCAT
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.
Device: Nautilus NeuroWaveTM System · Behavioral: SCAT
Recording of subjects with Nautilus NeuroWave diagnostic device
Also known as: Jan Medical Nautilus NeuroWave
A Neurocognitive evaluation of the patients to assess for concussion.
Also known as: Sports Concussion Assessment Test, SCAT2
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.
Time frame: Individual assessments were made within 2 days of recording
| Milestone | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| Started | 84 |
| Completed | 82 |
| Not completed | 2 |
| Withdrew: Protocol violation | 2 |
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.
| percentage of participants | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| Sensitivity | 77 (50 to 92) |
| Specificity | 87 (78 to 93) |
Collected over assessed from enrollment (baseline recording at beginning of sports season) to end of follow-up (end of sports season at 5 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic Device - Nautilus NeuroWave | — | 0/82 (0%) | 0/82 (0%) |
| Age, Categorical(Participants) | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| <=18 years | 80 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| Mean | 15.3 ± 1.33 |
| Sex/Gender, Customized(participants) | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| Males | 82 |
| Region of Enrollment(participants) | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| United States | 82 |
| Sport Concussion Assessment Tool- Second Edition (SCAT 2)(units on a scale) | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| Mean | 82.5 ± 10.2 |
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Jan Medical, Inc.