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Brain InjuriesBSC-CI-NPCNCT04074486

Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

An observational study of Brain Injuries and Concussion, Mild, run by BrainScope Company, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 50 yearsHealthy volunteers can take part
What is being tested?
BrainScope Ahead 300iP-O, SCAT5 and Near Point Convergence
Type of treatment
Medical device
How many people
1,318 participants
Where
6 sitesUnited States
Study dates
2 Oct 2019to 31 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Male and female study subjects aged 13-50 from participating sites will be invited to enroll the study.

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Michigan State University

    East Lansing, Michigan, 48824

  • INOVA Health System

    Fairfax, Virginia, 22042

  • University of Arkansas

    Fayetteville, Arkansas, 72701

  • University of Miami

    Miami, Florida, 33136

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Connecticut

    Storrs, Connecticut, 06269

Other trials in United States

About this study

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).

Read the 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.

Being tested
BrainScope Ahead 300iP-O, SCAT5, Near Point Convergence
Keywords
Concussion, Mild Traumatic Brain Injury, Automated/Electronic Near Point Convergence
Medical subject headings
Brain Injuries, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrainScope Ahead 300iP-ODevice

    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.

  • SCAT5Diagnostic test

    Sports Concussion Assessment Tool 5

  • Near Point ConvergenceDiagnostic test

    Manual ocular function measurement conducted only if electronic version on device fails

Study groups in NCT04074486
Study groupRoleWhat they receive
Injured and Matched Control SubjectsHead 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).
Receives: Device: BrainScope Ahead 300iP-O; Diagnostic Test: SCAT5; Diagnostic Test: Near Point Convergence
Healthy Volunteer SubjectsHealthy 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.
Receives: Device: BrainScope Ahead 300iP-O; Diagnostic Test: SCAT5; Diagnostic Test: Near Point Convergence
Non-Concussed Head Injured SubjectsA 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
Receives: Device: BrainScope Ahead 300iP-O; Diagnostic Test: SCAT5; Diagnostic Test: Near Point Convergence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity and Specificity of the multivariate and multimodal Concussion Index

    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.

    Measured: 18 months for data acquisition

Secondary outcomes (2)

  1. Efficacy of use

    The demonstration of efficacy of use of this biomarker of brain function impairment/concussion to assess readiness to return to normal activity

    Measured: 18 months for data acquisition

  2. Identification of concussion subtypes

    Validation of subtypes (at time of injury) with different clinical characterizations and outcome (e.g., rapid versus prolonged recovery).

    Measured: 18 months for data acquisition

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start2 Oct 2019
  3. Primary completion31 Jan 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074486
Sponsor's protocol ID
55/60
Acronym
BSC-CI-NPC
Status last verified
Jun 2022
First submitted
28 Aug 2019
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injuries and Concussion, Mild, run by BrainScope Company, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of the multivariate and multimodal Concussion Index (time frame: 18 months for data acquisition). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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