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

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.

Study Overview

• Status: Completed
• Conditions: Brain Concussion; Mild Traumatic Brain Injury
• Intervention / Treatment: Device: BrainPulse

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 Type: Observational
• Enrollment (Actual): 406

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deconess Medical Center Emergency Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0769
      • University of Cincinnati, Department of Emergency Medicine
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Mountain States Health Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients presenting to a hospital emergency department with a mechanism of injury and clinical presentation that is consistent with concussion

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: BrainPulse; 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.; Other Names: BrainPulse 1100

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The tertiary 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.	Through study completion, expected to be 1 year

Collaborators and Investigators

• Sponsor: Jan Medical, Inc.

Publications and helpful links

General Publications

• Auerbach PS, Baine JG, Schott ML, Greenhaw A, Acharya MG, Smith WS. Detection of concussion using cranial accelerometry. Clin J Sport Med. 2015 Mar;25(2):126-32. doi: 10.1097/JSM.0000000000000117.
• Smith WS, Browne JL, Ko NU. Cranial Accelerometry Can Detect Cerebral Vasospasm Caused by Subarachnoid Hemorrhage. Neurocrit Care. 2015 Dec;23(3):364-9. doi: 10.1007/s12028-015-0118-9.
• Coscia A, Stolz U, Barczak C, Wright N, Mittermeyer S, Shams T, Epstein S, Kreitzer N. Use of the Sports Concussion Assessment Tool 3 in Emergency Department Patients With Psychiatric Disease. J Head Trauma Rehabil. 2021 Sep-Oct 01;36(5):E302-E311. doi: 10.1097/HTR.0000000000000648.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: JMC-1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All primary and secondary outcome measures will be made available within 6 months of study completion.