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

Terminated

• Conditions: Mild Traumatic Brain Injury
• Interventions: Device: BrainPulse

• Registration Number: NCT02849002
• Lead Sponsor: Jan Medical, Inc.

Brief 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.

Study Timeline

• Study Start: 2016-07-14
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Primary Completion: 2016-09-29
• Study Completion: 2016-09-29
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age > 13 years old and not part of any other vulnerable population such as pregnant women.

2. Suspected or confirmed concussion by medical professional

3. Not more than 3 days since injury/trauma event

4. Willing and able to participate in all required study evaluations and allow access to medical testing and records

5. Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject.

6. 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

1. Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
2. 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
3. Currently participating in or planning to participate in another clinical study during the course of the current clinical study.
4. Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)
5. An alternative diagnosis is made other than concussion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interventional Device	BrainPulse	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.

Primary Outcome Measures

Name	Time	Method
Number of BrainPulse recordings from suspected and confirmed concussed subjects	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Konkussion Inc.; 🇨🇦 Woodbridge, Ontario, Canada