Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
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|ClinicalTrials.gov Identifier: NCT02849002|
Recruitment Status : Unknown
Verified August 2016 by Jan Medical, Inc..
Recruitment status was: Recruiting
First Posted : July 29, 2016
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury||Device: BrainPulse||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2017|
Experimental: Interventional Device
The BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the brain motion caused by pulsatile blood flow from the cardiac cycle.
The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile blood flow. The system is powered by rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors.
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.
Other Name: BrainPulse 1100
- Number of BrainPulse recordings from suspected and confirmed concussed subjects [ Time Frame: Through study completion, expected to be 6 months ]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.The primary endpoint is to enroll and record BrainPulse signals from 500 subjects with a suspected concussion. To gather sufficiently diverse data, at least 300 participants will have had a confirmed diagnosis of concussion. The data will be used to improve the algorithm for aiding in the diagnosis of concussion.
- Average number of days the signal pattern seen within BrainPulse recordings from confirmed concussed subjects from the initial recording persist over the course of the 21 day follow up period. [ Time Frame: Through study completion, expected to be 1 year] ]The secondary endpoint is to assess the differences in BrainPulse recordings between the initial visit and each subsequent follow-up visit to better understand the recovery process post concussion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849002
|Contact: Hiba Lejmi, MDemail@example.com|
|Contact: Prabhu Raghavan, MS, MBA||(650) 567 firstname.lastname@example.org|
|Woodbridge, Ontario, Canada, L4L9R6|
|Contact: Neilan K. Jha, MD 416-427-2206 email@example.com|
|Contact: Megan Macquarrie 416-427-2206 firstname.lastname@example.org|