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

NCT ID: NCT02660164

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-03-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A: High-Risk of Concussion

Middle school, high school and college athletes of either gender participating in sports where high-risk of concussion is anticipated: football, soccer, lacrosse, hockey, basketball, ice hockey, field hockey, rugby, cheerleading, boxing, and gymnastics.

Nautilus BrainPulse Recording

Intervention Type: DEVICE

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).

Cohort B: Low-Risk of Concussion

Middle school, high school and college athletes of either gender participating in sports where low-risk of concussion is anticipated: swimming, track, volleyball, baseball, softball and golf.

Nautilus BrainPulse Recording

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jan Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Abrams, MD,

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco Medical Center

Locations

Meli Orthopedic Centers of Excellence

Fort Lauderdale, Florida, United States

Community Hospital

Munster, Indiana, United States

Louisiana State University

Baton Rouge, Louisiana, United States

University of Wyoming

Laramie, Wyoming, United States

Countries

United States

Other Identifiers

JMC-1501

Identifier Type: -

Identifier Source: org_study_id