Last updated: June 8, 2022
Sponsor: Jan Medical, Inc.
Overall Status: Completed
Phase
N/A
Condition
Brain Injury
Treatment
N/AClinical Study ID
NCT02660164
JMC-1501
Ages 10-25 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subjects between 10 and 25 years of age (middle school, high school orcollege-age)
- Team member, where the team meets at least twice a week
- Willing and able to participate in all study evaluations and allow access to medicaltesting and records
- 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:
- Documented history of a concussion diagnosed by a physician in the last two monthsassessed via interview with athlete
- Known history of any cognitive deficits that diminish ability to administer studyassessments, such as SCAT3™
- Wound on the head in the area of one of the Nautilus BrainPulse sensors that wouldimpede use of the Nautilus BrainPulse device
- Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion
- 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
Connect with a study center
Meli Orthopedic Centers of Excellence
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Community Hospital
Munster, Indiana 46321
United StatesSite Not Available
Louisiana State University
Baton Rouge, Louisiana 70803
United StatesSite Not Available
University of Wyoming
Laramie, Wyoming 82070
United StatesSite Not Available

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