Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries
- Sponsor
- BrainScope Company, Inc.
- Enrollment
- 1318
- Locations
- 6
- Primary Endpoint
- Sensitivity and Specificity of the multivariate and multimodal Concussion Index
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
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.
Investigators
Eligibility 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;
Outcomes
Primary Outcomes
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 Outcomes
- Efficacy of use(18 months for data acquisition)
- Identification of concussion subtypes(18 months for data acquisition)