A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
Completed
Conditions studied: Concussion
In brief
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.
Key facts
- Study ID
- NCT02660164
- Run by
- Jan Medical, Inc.
- People needed
- 149
- Starts
- 2015-11-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2022-06-09
Who can join
Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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