Concussion Testing: A Novel Non-invasive Concussion Detection Device

Completed

• Conditions: Concussion

• 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

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Results First Submitted: 2015-06-02
• Results First Submitted QC: 2017-03-09
• Results First Posted: 2017-04-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

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

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.

Trial Locations

Locations (1)

Los Altos High School; 🇺🇸 Los Altos, California, United States