Control Study of Nautilus BrainPulse for the Detection of Concussion

Jan Medical

Status: Completed

Conditions: Brain Concussion

Treatments: Device: Nautilus BrainPulse

Study type: Observational

Funder types: Industry

Identifiers

NCT02350699

Normal-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 14 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

22 participants in 1 patient group

Control

Description:

Nautilus BrainPulse

Treatment:

Device: Nautilus BrainPulse