Control Study of Nautilus BrainPulse for the Detection of Concussion

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350699
• Other study ID #: Normal-001
• Status: Completed
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2022
• Source: Jan Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion

Intervention

Device:
• Nautilus BrainPulse
A noninvasive device to detect concussion utilizing headset and sensors

Locations

Country	Name	City	State
United States	Jan Medical, Inc.	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Jan Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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