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Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC (BSC-CI-NPC)

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: NCT04074486
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
BrainScope Company, Inc.

Brief Summary:
This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).

Condition or disease Intervention/treatment
Brain Injuries Concussion, Mild Concussion, Brain Near Point Convergence Concussion, Intermediate Device: BrainScope Ahead 300iP-O Diagnostic Test: SCAT5 Diagnostic Test: Near Point Convergence

Detailed Description:
Phase 1 of this project (USAMRDC W81XWH-18-C-0157) was focused on building the automated/electronic NPC capability (eNPC). This protocol is for Phase 2, in which the CI multimodal brain function biomarker will be extended (Algorithm Development) with the inclusion of an automated ocular function measurement (AOFM), to expand the capability in the characterization of concussion. The study will also expand the range of applicability of the CI to ages 13-50 years old. Phase 2 will also include norming of eNPC across the age range. Phase 3 of the project will validate the algorithms developed in Phase 2, using the same protocol.

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : April 30, 2021

Group/Cohort Intervention/treatment
Injured and Matched Control Subjects
Head Injured subjects are defined as those who sustained a closed head injury and meet specified protocol inclusion/exclusion criteria. Matched Control subjects are enrolled based on matching criteria (for e.g. age, gender, and same population i.e. sports vs non-sports) to the head injured subjects. For all head injured and matched control group subjects, the full battery of tests will be performed. The injured pool will begin test procedures when a subject sustains a concussion injury. The matched control pool will follow the same time point/date interval as their matched injured subject. The matched control will be assigned by site to an injured subject and matched by age, gender, and sport (if applicable) or from the same population (if non-sport).
Device: BrainScope Ahead 300iP-O
BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.

Diagnostic Test: SCAT5
Sports Concussion Assessment Tool 5

Diagnostic Test: Near Point Convergence
Manual ocular function measurement conducted only if electronic version on device fails

Healthy Volunteer Subjects
Healthy Volunteer subjects are defined as those who are normal subjects i.e. not head-injured meeting specified protocol inclusion/exclusion criteria.This group of subjects are recruited only for the purpose of collecting data for norming the electronic near point convergence measurement (eNPC). These subjects will only perform a limited battery of BrainScope tests at a single visit and will include data collection regarding their demographics, concussion history, signs and symptoms, sports information, etc. These subjects will not undergo EEG or neurocognitive assessment.
Device: BrainScope Ahead 300iP-O
BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.

Diagnostic Test: SCAT5
Sports Concussion Assessment Tool 5

Diagnostic Test: Near Point Convergence
Manual ocular function measurement conducted only if electronic version on device fails

Non-Concussed Head Injured Subjects
A secondary group of non-concussed head-injured controls shall be also recruited who were observed to have a head impact/injury but were not restricted from play within the same game or deemed non-concussed following on-field/sideline evaluation by the standard of care at each site. They will perform the entire BrainScope battery of tests within 5 days after the incident and defined as Day 0 and a follow-up assessment at 15 Days following Day0
Device: BrainScope Ahead 300iP-O
BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.

Diagnostic Test: SCAT5
Sports Concussion Assessment Tool 5

Diagnostic Test: Near Point Convergence
Manual ocular function measurement conducted only if electronic version on device fails




Primary Outcome Measures :
  1. Sensitivity and Specificity of the multivariate and multimodal Concussion Index [ Time Frame: 18 months for data acquisition ]
    Sensitivity and specificity of the expanded CI for assessment of the likelihood of concussion in subjects ages 13-50 who sustained a closed head injury.


Secondary Outcome Measures :
  1. Efficacy of use [ Time Frame: 18 months for data acquisition ]
    The demonstration of efficacy of use of this biomarker of brain function impairment/concussion to assess readiness to return to normal activity

  2. Identification of concussion subtypes [ Time Frame: 18 months for data acquisition ]
    Validation of subtypes (at time of injury) with different clinical characterizations and outcome (e.g., rapid versus prolonged recovery).



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:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female study subjects aged 13-50 from participating sites will be invited to enroll the study.
Criteria

Inclusion Criteria:

  • Age ≥13 and <51 years old at time of enrollment;
  • No prior history of concussion or TBI in the last 6 months.

For head injured subjects

  • Having sustained a traumatic closed head injury within 120 hours (5 days from time of injury at time of BrainScope assessment);
  • GCS 13-15 at time of BrainScope assessment.

For non-concussed head-injured controls

  • Having sustained a traumatic closed head injury but returned to play or deemed non-concussed following sideline (on-field) evaluation within the same game and enrolled in the study within 120 hours (5 days) from said incident.
  • GCS 13-15 at time of BrainScope assessment.

For matched controls and healthy volunteers

• GCS 15 at time of BrainScope assessment.

Exclusion Criteria:

  • Enrolled in any previous BrainScope clinical study;
  • Current CNS active prescription medications taken daily, except for medication being taken for the treatment of Attention Deficit Disorders (ADD/ADHD); medication for smoking cessation; or medications for anxiety taken PRN (as needed);
  • Forehead, scalp or skull abnormalities that prevents headset application for EEG data collection in injured/matched controls;
  • History of brain tumor, brain surgery or known neurological disease including, Parkinson's, MS, Alzheimer's, dementia, epilepsy;
  • History of TIA or Stroke within the last year;
  • Pregnant women;
  • Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
  • Acute intoxication ;
  • Evidence of illicit drug abuse in the last year;
  • Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
  • Subjects currently receiving dialysis or have end-stage renal disease;
  • Subjects requiring advanced airway management (i.e. mechanical ventilation);
  • Prisoners.

For head injured subjects

  • Loss of consciousness ≥ 20 minutes related to the concussion injury;
  • Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (note: neuroimaging is not required for enrollment);
  • For current injury, hospital admission (other than the Observation Unit) ranging more than 24 hours due to either head injury or collateral injuries.

For non-concussed head-injured controls

  • Loss of consciousness ≥ 20 minutes related to the head impact;
  • Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
  • Any score >3 on a 7-point Likert scale (0=none, 6=severe) for the following symptoms at the time of BrainScope assessment (compared to how the subject normally feels): headache, dizziness, balance problems, neck pain, feeling slowed down;

For matched controls and healthy volunteers

  • Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
  • Hospital admission (other than the Observation Unit) ranging more than 24 hours due to either head injury or collateral injuries in the past 6 months;
  • Any score >3 on a 7-point Likert scale (0=none, 6=severe) for the following symptoms at the time of BrainScope assessment (compared to how the subject normally feels): headache, dizziness, balance problems, neck pain, feeling slowed down.

For healthy volunteers

  • Legally blind in one or both eyes;
  • History of eye surgery in the past year;
  • Any known eye disorders including age-related macular degeneration (AMD), glaucoma, lazy eye, diplopia, cataracts, etc.

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): NCT04074486


Contacts
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Contact: Judith Anticola 716-675-3222 judith.anticola@brainscope.com
Contact: Saloni Kanakia 240-752-7680 ext 1042 kanakia.saloni@gmail.com

Locations
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United States, Arkansas
University of Arkansas Recruiting
Fayetteville, Arkansas, United States, 72701
Contact: Robert J Elbin, Ph.D.    479-575-5262    rjelbin@uark.edu   
United States, Connecticut
University of Connecticut Recruiting
Storrs, Connecticut, United States, 06269
Contact: Douglas Casa, PhD    860-429-7720    douglas.casa@uconn.edu   
Contact: Jeb Sctruder, MS    860-486-2647    jeb.struder@uconn.edu   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Gillian Hotz, Ph.D.    305-243-4004    GHotz@med.miami.edu   
United States, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Tracey Covassin, Ph.D.    517-353-2100    covassin@msu.edu   
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Kian Merchant-Borna, MPH MBA    585-275-2909    kian_merchant-borna@urmc.rochester.edu   
Principal Investigator: Jeffrey Bazarian, MD, MPH         
United States, Virginia
INOVA Health System Recruiting
Fairfax, Virginia, United States, 22042
Contact: Melissa Womble    703-970-6464    melissa.womble@inova.org   
Principal Investigator: Melissa Womble, Ph.D.         
Principal Investigator: Robert J Elbin, Ph.D.         
Sponsors and Collaborators
BrainScope Company, Inc.
United States Department of Defense
Investigators
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Study Director: Leslie Prichep, Ph.D. BrainScope Company, Inc.
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Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT04074486    
Other Study ID Numbers: 55/60
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by BrainScope Company, Inc.:
Concussion
Mild Traumatic Brain Injury
Automated/Electronic Near Point Convergence
Additional relevant MeSH terms:
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Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Injuries, Traumatic
Head Injuries, Closed
Wounds, Nonpenetrating