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.
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.
Study Type
OBSERVATIONAL
Enrollment
149
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).
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
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.
Time frame: 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.