Concussion Testing: A Novel Non-invasive Concussion Detection Device

Completed

Conditions: Concussion

Interventions: Device: Nautilus NeuroWaveTM System
Behavioral: SCAT

Registration Number: NCT02370914

Lead Sponsor: Jan Medical, Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 84

Inclusion Criteria

Junior Varsity and Varsity Players a local High School.

Exclusion Criteria

None

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	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.
Suspected Concussive Event (SCE)	SCAT	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.
Suspected Concussive Event (SCE)	Nautilus NeuroWaveTM System	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.
Control	Nautilus NeuroWaveTM System	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures