Concussion Testing: A Novel Non-invasive Concussion Detection Device

Concussion Clinical Trial

Official title:

Concussion Testing: A Novel Non-invasive Concussion Detection Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370914
• Other study ID #: 21114
• Status: Completed
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2022
• Source: Jan Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to establish and evaluate a distinctive signal for concussion.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Junior Varsity and Varsity Players a local High School.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Concussion

Intervention

Device:
• Nautilus NeuroWaveTM System
Recording of subjects with Nautilus NeuroWave diagnostic device

Behavioral:
• SCAT
A Neurocognitive evaluation of the patients to assess for concussion.

Locations

Country	Name	City	State
United States	Los Altos High School	Los Altos	California

Sponsors (1)

Lead Sponsor	Collaborator
Jan Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Individual assessments were made within 2 days of recording