Concussion
Conditions
Keywords
Concussion
Brief summary
The purpose of this study is to establish and evaluate a distinctive signal for concussion.
Detailed description
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
Interventions
Recording of subjects with Nautilus NeuroWave diagnostic device
BEHAVIORALSCAT
A Neurocognitive evaluation of the patients to assess for concussion.
Sponsors
Jan Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
14 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Junior Varsity and Varsity Players a local High School.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data | Individual assessments were made within 2 days of recording | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Diagnostic Device - Nautilus NeuroWave |
|---|---|
| Age, Categorical <=18 years | 80 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 15.3 years STANDARD_DEVIATION 1.33 |
| Region of Enrollment United States | 82 participants |
| Sex/Gender, Customized Males | 82 participants |
| Sport Concussion Assessment Tool- Second Edition (SCAT 2) | 82.5 units on a scale STANDARD_DEVIATION 10.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
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.
Time frame: Individual assessments were made within 2 days of recording
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic Device - Nautilus NeuroWave | A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data | Sensitivity | 77 percentage of participants |
| Diagnostic Device - Nautilus NeuroWave | A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data | Specificity | 87 percentage of participants |