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

June 8, 2022 updated by: BrainScope Company, Inc.
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • University of Arkansas
    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Inova Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
18 months for data acquisition

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
18 months for data acquisition
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).
18 months for data acquisition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BrainScope Company, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 55/60

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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