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

Jan Medical

Status: Completed

Conditions: Mild Traumatic Brain Injury; Brain Concussion

Treatments: Device: BrainPulse

Study type: Observational

Funder types: Industry

Identifiers

NCT02812225

JMC-1502

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 406 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >= 5 years old

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)

Trial design

406 participants in 1 patient group

BrainPulse

Description:

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.

Treatment:

Device: BrainPulse