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

NCT02660164 | Completed

• 1 other identifier: JMC-1501
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 4

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.

Conditions

Concussion

Keywords

Concussion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Device: Nautilus BrainPulse Recording

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.

Device: Nautilus BrainPulse Recording

Interventions

Nautilus BrainPulse Recording 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 A: High-Risk of Concussion; Cohort B: Low-Risk of Concussion

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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. 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.

You may qualify if:

• Male or female subjects between 10 and 25 years of age (middle school, high school or college-age)
• Team member, where the team meets at least twice a week
• Willing and able to participate in all study evaluations and allow access to medical testing and records
• 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

You may not qualify if:

• Documented history of a concussion diagnosed by a physician in the last two months assessed via interview with athlete
• Known history of any cognitive deficits that diminish ability to administer study assessments, such as SCAT3™
• Wound on the head in the area of one of the Nautilus BrainPulse sensors that would impede use of the Nautilus BrainPulse device
• Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion
• 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

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (4)

Meli Orthopedic Centers of Excellence

Fort Lauderdale, Florida, 33308, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Louisiana State University

Baton Rouge, Louisiana, 70803, United States

Location

University of Wyoming

Laramie, Wyoming, 82070, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Gary Abrams, MD,

  University of California San Francisco Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 21, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

US (4)