Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

Status Completed

Clinical Trial Summary

The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm. Subjects may also consent for a 5 additional follow-ups over a 21-day period to compare the progression of change in their BrainPulse recordings.

Clinical Trial Description

The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. In order to gather sufficient variability, subjects with both confirmed concussion and suspected concussion will be included in the study as long as they meet eligibility criteria. BrainPulse recordings from subjects with suspected concussion will be compared to the recordings of subjects diagnosed with concussion. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02812225
Study type	Observational
Source	Jan Medical, Inc.
Contact
Status	Completed
Phase
Start date	June 2016
Completion date	January 2019

View Details

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