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Control Study of Nautilus BrainPulse for the Detection of Concussion

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02350699
Enrollment
22
Registered
2015-01-30
Start date
2015-01-31
Completion date
2015-05-31
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion

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.

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.

Interventions

DEVICENautilus BrainPulse

A noninvasive device to detect concussion utilizing headset and sensors

Sponsors

Jan Medical, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport4 monthsBrainPulse 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026