NCT02849002

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

Non-Blinded Data Collection Study Of Concussion Using The BrainPulse

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Jan Medical, Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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. 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.BrainPulse(TM)

Detailed description

Jan Medical is conducting a data collection study with the goal of developing further insight into understanding the signal features within a BrainPulse recording that are only present when the subject has a confirmed concussion. The initial pilot blinded study with Stanford University showed that there is increased energy in the 8-15 Hz range for BrainPulse recordings from adolescent male football players with a confirmed concussion. The current un-blinded study is designed to record the BrainPulse signal from a more diverse subject population to represent patients who have been diagnosed with a concussion in clinic setting. Subjects will include males and females ages 13 and older.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	BrainPulse	Jan Medical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle, referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to the brain motion using an array of sensors placed on the head.

Timeline

• Start date: 2016-07-14
• Primary completion: 2016-09-29
• Completion: 2016-09-29
• First posted: 2016-07-29
• Last updated: 2023-07-07

Locations

1 site across 1 country: Canada