Control Study of Nautilus BrainPulse for the Detection of Concussion

June 30, 2022 updated by: Jan Medical, Inc.

Non Blinded Control Study of High School Athletes in Non Contact Sports

To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.

The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94041
        • Jan Medical, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are healthy controls and participate in a non-contact sport at the high school level.

Description

Inclusion Criteria:

  • Male and female between 14 and 19 years of age
  • Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
  • Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf

Exclusion Criteria:

  • History, if any, of concussion or stroke
  • History, if any, of alcohol or drug abuse
  • History, if any, of mental disorder or cerebrovascular disorder
  • Pregnant women
  • Failure to comply with recording schedule
  • Not suitable for participation in the study in the opinion of the PI
  • Have suffered a concussion during the study
  • Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country)
  • Related to a Jan Medical employee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Nautilus BrainPulse
Device: Nautilus BrainPulse
A noninvasive device to detect concussion utilizing headset and sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
Time Frame: 4 months
BrainPulse recordings collected in this study will be used as an age-matched control cohort for comparison with already collected concussion data that is under development for identifying a concussion algorithm. The device recordings will be visually compared for similarities and differences using data mining practices looking for features that are consistent between the concussion subjects and healthy normals.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Medical, Inc.

Investigators

  • Principal Investigator: Paul Lovoi, PhD, Jan Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Normal-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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