Concussion Testing: A Novel Non-invasive Concussion Detection Device

NCT02370914 | Completed Results

• 1 other identifier: 21114
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Concussion

Keywords

Concussion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Suspected Concussive Event (SCE)

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.

Device: Nautilus NeuroWaveTM System; Behavioral: SCAT

Control

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.

Device: Nautilus NeuroWaveTM System; Behavioral: SCAT

Interventions

Nautilus NeuroWaveTM System DEVICE

Recording of subjects with Nautilus NeuroWave diagnostic device

Also known as: Jan Medical Nautilus NeuroWave

Control; Suspected Concussive Event (SCE)

SCAT BEHAVIORAL

A Neurocognitive evaluation of the patients to assess for concussion.

Also known as: Sports Concussion Assessment Test, SCAT2

Control; Suspected Concussive Event (SCE)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Varsity high school football players at a local High School.

You may qualify if:

• Junior Varsity and Varsity Players a local High School.

You may not qualify if:

• None

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (1)

Los Altos High School

Los Altos, California, 94022, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This is a pilot study only. Only 15 concussions were observed from a single gender teenage population from one high school football team over one season. Further data from a broader population is needed to confirm results.

Results Point of Contact

• Title: Dr. Paul Auerbach
• Organization: Stanford University

auerbach@stanford.edu

(650) 725-9445

Study Officials

• Paul S Auerbach

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2015
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 2, 2022
• Results First Posted: April 20, 2017

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)