A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion

Last updated: June 8, 2022
Sponsor: Jan Medical, Inc.
Overall Status: Completed

Phase

N/A

Condition

Brain Injury

Treatment

N/A

Clinical Study ID

NCT02660164
JMC-1501
  • Ages 10-25
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects between 10 and 25 years of age (middle school, high school orcollege-age)
  2. Team member, where the team meets at least twice a week
  3. Willing and able to participate in all study evaluations and allow access to medicaltesting and records
  4. Signed informed consent, or have a legally authorized representative willing toprovide informed consent on behalf of the subject if the subject is a minor

Exclusion

Exclusion Criteria:

  1. Documented history of a concussion diagnosed by a physician in the last two monthsassessed via interview with athlete
  2. Known history of any cognitive deficits that diminish ability to administer studyassessments, such as SCAT3™
  3. Wound on the head in the area of one of the Nautilus BrainPulse sensors that wouldimpede use of the Nautilus BrainPulse device
  4. Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion
  5. Any serious medical, social or psychological condition that in the opinion of theinvestigator would impair ability to provide informed consent or otherwise disqualifya patient from participation

Study Design

Total Participants: 149
Study Start date:
November 01, 2015
Estimated Completion Date:
March 31, 2019

Study Description

This is a prospective, non-randomized, blinded, matched control study of young athletes (ages 10-25 years old) in competitive sports (Cohort A: higher-risk of concussion, Cohort B: lower-risk of concussion) to assess the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.

The Nautilus BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the brain pulse, the brain motion caused by pulsatile blood flow from the cardiac cycle. The Nautilus BrainPulse analyzes the captured data to provide an aid in diagnosing an episode of concussion.

Connect with a study center

  • Meli Orthopedic Centers of Excellence

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Community Hospital

    Munster, Indiana 46321
    United States

    Site Not Available

  • Louisiana State University

    Baton Rouge, Louisiana 70803
    United States

    Site Not Available

  • University of Wyoming

    Laramie, Wyoming 82070
    United States

    Site Not Available

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