Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

NCT04074486 | Completed FDA Device

• 1 other identifier: 55/60
• Study Type: observational
• Target: 1,318
• Locations: 1 country
• Sites: 6

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).

Conditions

Brain Injuries; Concussion, Mild; Concussion, Brain; Near Point Convergence; Concussion, Intermediate

Keywords

Concussion; Mild Traumatic Brain Injury; Automated/Electronic Near Point Convergence

Outcome Measures

Primary Outcomes (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.

  18 months for data acquisition

Secondary Outcomes (2)

• Efficacy of use

  18 months for data acquisition

• Identification of concussion subtypes

  18 months for data acquisition

Study Arms (3)

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; Diagnostic Test: SCAT5; Diagnostic Test: Near Point Convergence

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; Diagnostic Test: SCAT5; Diagnostic Test: Near Point Convergence

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; Diagnostic Test: SCAT5; Diagnostic Test: Near Point Convergence

Interventions

BrainScope Ahead 300iP-O DEVICE

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.

Healthy Volunteer Subjects; Injured and Matched Control Subjects; Non-Concussed Head Injured Subjects

SCAT5 DIAGNOSTIC_TEST

Sports Concussion Assessment Tool 5

Healthy Volunteer Subjects; Injured and Matched Control Subjects; Non-Concussed Head Injured Subjects

Near Point Convergence DIAGNOSTIC_TEST

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

Healthy Volunteer Subjects; Injured and Matched Control Subjects; Non-Concussed Head Injured Subjects

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• BrainScope Company, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (6)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

INOVA Health System

Fairfax, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Leslie Prichep, Ph.D.

  BrainScope Company, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: October 2, 2019
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

US (6)