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

Completed

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

• Registration Number: NCT02812225
• Lead Sponsor: Jan Medical, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BrainPulse	BrainPulse	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.

Primary Outcome Measures

Name	Time	Method
Number of BrainPulse recordings from suspected and confirmed concussed subjects	Through study completion, expected to be 1 year	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
Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects	Through study completion, expected to be 1 year	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.

Trial Locations

Locations (3)

Beth Israel Deconess Medical Center Emergency Medicine; 🇺🇸 Boston, Massachusetts, United States

University of Cincinnati, Department of Emergency Medicine; 🇺🇸 Cincinnati, Ohio, United States

Mountain States Health Alliance; 🇺🇸 Johnson City, Tennessee, United States