Control Study of Nautilus BrainPulse for the Detection of Concussion

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.

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Key information

Conditions

Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jan Medical, Inc.

Mountain View, California, 94041, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nautilus BrainPulse

Device

A noninvasive device to detect concussion utilizing headset and sensors

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Jan Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 30, 2015
Registry last updated: Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed