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

Jan Medical

Status: Terminated

Conditions: Mild Traumatic Brain Injury

Treatments: Device: BrainPulse

Study type: Observational

Funder types: Industry

Identifiers

NCT02849002

JMC-1601-P01

Details and patient eligibility

About

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)

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Interventional Device

Description:

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.

Treatment:

Device: BrainPulse