An observational study in Mild Traumatic Brain Injury, sponsored by Jan Medical, Inc.. Terminated at 1 site in Canada. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Jan Medical, Inc. · Observational
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)
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.
2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 25 is below the median of 100 across 689 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →Jan Medical, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children and adults, ages 13 and older, who are diagnosed with a concussion or mild Traumatic Brain Injury (mTBI), typically due to a trauma event such as a fall, sports injury, motor vehicle accident, etc.
Demonstrates a minimum of 3 of the following symptoms:
Exclusion Criteria:
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.
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.
Also known as: BrainPulse 1100
Number of BrainPulse recordings from suspected and confirmed concussed subjects
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.
Time frame: Through study completion, expected to be 6 months
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.
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.
Time frame: Through study completion, expected to be 1 year]
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Jan Medical, Inc.