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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Brain Concussion, Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: BrainPulse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 5 years old Suspected or confirmed concussion by medical professional Not more than 3 days since injury/trauma event Willing and able to participate in all required study evaluations and allow access to medical testing and records Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject Demonstrates a minimum of 3 of the following symptoms: Headache Pressure in head Dizziness Neck pain Fatigue/ low energy Nausea or vomiting Irritability Difficulty in concentrating/performing tasks Memory impairment Insomnia Reduced tolerance to stress Sensitivity to light Difficulty balancing Blurred vision Confusion More emotional than usual Sadness Nervous/Anxious Vacant stare Delayed verbal/motor response 'Feeling like in a fog' 'Don't feel right' Exclusion Criteria: Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device Any serious medical condition that in the opinion of the medical professional would impair ability to provide informed consent/assent or otherwise disqualify a patient from participation Currently participating in or planning to participate in another clinical study during the course of the current clinical study Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BrainPulse<br>BrainPulse recordings will be obtained from patients when they come in to the ED after a trauma event. BrainPulse recordings will be also obtained from those subjects who also consent for follow-up. | Device: BrainPulse<br>* 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.<br>* Other names: BrainPulse 1100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BrainPulse recordings from suspected and confirmed concussed subjects | 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. | Through study completion, expected to be 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects | The secondary endpoint is to compare the BrainPulse readings from patients with confirmed concussion with patients with a suspected concussion in order to study the differences and similarities between the signals. The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from suspected concussed subjects who are later confirmed to not have a concussion and the percentage of such subjects will be evaluated as part of the secondary outcome. This can be seen as a specificity evaluation. | Through study completion, expected to be 1 year |