Control Study of Nautilus BrainPulse for the Detection of Concussion
Non Blinded Control Study of High School Athletes in Non Contact Sports
1 other identifier
observational
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 6, 2022
June 1, 2022
4 months
January 20, 2015
June 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
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
Study Arms (1)
Control
Nautilus BrainPulse
Interventions
A noninvasive device to detect concussion utilizing headset and sensors
Eligibility Criteria
Subjects who are healthy controls and participate in a non-contact sport at the high school level.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jan Medical, Inc.
Mountain View, California, 94041, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Lovoi, PhD
Jan Medical, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 30, 2015
Study Start
January 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 6, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share