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Completed

NCT Number: NCT02370914

Concussion Testing: A Novel Non-invasive Concussion Detection Device

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

Completed

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Key information

Conditions

Concussion Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Los Altos High School

Los Altos, California, 94022, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Junior Varsity and Varsity Players a local High School.

Exclusion criteria

  • None

Treatment and study plan

Nautilus NeuroWaveTM System

Device

Recording of subjects with Nautilus NeuroWave diagnostic device

Other names: Jan Medical Nautilus NeuroWave

SCAT

Behavioral

A Neurocognitive evaluation of the patients to assess for concussion.

Other names: Sports Concussion Assessment Test, SCAT2

Primary outcomes

  1. A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jan Medical, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2015
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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