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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812225
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Concussion Mild Traumatic Brain Injury Device: BrainPulse Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: 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 Name: BrainPulse 1100




Primary Outcome Measures :
  1. Number of BrainPulse recordings from suspected and confirmed concussed subjects [ Time Frame: 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 :
  1. Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects [ Time Frame: 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.


Other Outcome Measures:
  1. 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. [ Time Frame: Through study completion, expected to be 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812225


Contacts
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Contact: Prabhu Raghavan, MS, MBA (650) 567 4611 praghavan@janmedical.com
Contact: Hiba Lejmi, MD (650) 316 8068 hlejmi@janmedical.com

Locations
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United States, Massachusetts
Beth Israel Deconess Medical Center Emergency Medicine Recruiting
Boston, Massachusetts, United States, 02215
Contact: Elinita Rosseto    617-754-2334    erosseto@bidmc.harvard.edu   
Contact: Ted Raddell    (617) 754-2334      
Principal Investigator: Stephen Epstein, MD, MPP         
United States, Ohio
University of Cincinnati, Department of Emergency Medicine Recruiting
Cincinnati, Ohio, United States, 45267-0769
Contact: Christopher Barczak, MT, CCRP    513-558-8091    christopher.barczak@uc.edu   
Contact: Cristina Spinner, CCRP    (513) 558-0698    cristina.spinner@uc.edu   
Principal Investigator: Natalie Kreitzer, MD         
United States, Tennessee
Mountain States Health Alliance Recruiting
Johnson City, Tennessee, United States, 37604
Contact: Christy Adkins    423-431-5647    adkinsCE2@msha.com   
Contact: Nonna Stepanov, MD    (423) 431-5647    StepanovNV@msha.com   
Principal Investigator: Tanzid Shams, MD         
Sponsors and Collaborators
Jan Medical, Inc.
Publications:
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Responsible Party: Jan Medical, Inc.
ClinicalTrials.gov Identifier: NCT02812225    
Other Study ID Numbers: JMC-1502
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All primary and secondary outcome measures will be made available within 6 months of study completion.
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating