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

Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660164
• Other study ID #: JMC-1501
• Status: Completed
• Start date: November 2015
• Est. completion date: March 2019

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects between 10 and 25 years of age (middle school, high school or college-age)

2. Team member, where the team meets at least twice a week

3. Willing and able to participate in all study evaluations and allow access to medical testing and records

4. Signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor

Exclusion Criteria:

1. Documented history of a concussion diagnosed by a physician in the last two months assessed via interview with athlete

2. Known history of any cognitive deficits that diminish ability to administer study assessments, such as SCAT3™

3. Wound on the head in the area of one of the Nautilus BrainPulse sensors that would impede use of the Nautilus BrainPulse device

4. Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion

5. Any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation

Related Conditions & MeSH terms

• Concussion

Intervention

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).

Locations

Country	Name	City	State
United States	Louisiana State University	Baton Rouge	Louisiana
United States	Meli Orthopedic Centers of Excellence	Fort Lauderdale	Florida
United States	University of Wyoming	Laramie	Wyoming
United States	Community Hospital	Munster	Indiana

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	Sensitivity and Specificity of the Nautilus Brain Pulse in detecting concussion as compared to adjudication by a panel of medical experts	Sensitivity and Specificity of the Nautilus BrainPulse in detecting the number of subjects experiencing concussion as compared to the number of subjects with concussion as adjudicated by a panel of medical experts. BrainPulse measurement data will be aggregated by subject over the first 10-days of recording after the concussive event, or for subjects in the Control arm, after their selection as a control subject.	10 days