NCT02660164

A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: Jan Medical, Inc. · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.

Detailed description

This is a prospective, non-randomized, blinded, matched control study of young athletes (ages 10-25 years old) in competitive sports (Cohort A: higher-risk of concussion, Cohort B: lower-risk of concussion) to assess the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion. The Nautilus BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the brain pulse, the brain motion caused by pulsatile blood flow from the cardiac cycle. The Nautilus BrainPulse analyzes the captured data to provide an aid in diagnosing an episode of concussion.

Conditions

• Concussion

Interventions

Type	Name	Description
DEVICE	Nautilus BrainPulse Recording	Comparison of Nautilus BrainPulse recordings in subjects who have a concussive event (Cohort A) to Nautilus BrainPulse recording in subjects who do not experience a concussive events (Cohort B or matched subjects to Cohort A). Recordings are obtained over a 2 week period every 2 to 3 days (at least 5 recordings per subject).

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-01-21
• Last updated: 2022-06-09

Locations

4 sites across 1 country: United States