Control Study of Nautilus BrainPulse for the Detection of Concussion

Completed

• Conditions: Brain Concussion
• Interventions: Device: Nautilus BrainPulse

• Registration Number: NCT02350699
• Lead Sponsor: Jan Medical, Inc.

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Nautilus BrainPulse	Nautilus BrainPulse

Primary Outcome Measures

Name	Time	Method
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport	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.

Trial Locations

Locations (1)

Jan Medical, Inc.; 🇺🇸 Mountain View, California, United States