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).
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
OBSERVATIONAL
Enrollment
1,318
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.
Sports Concussion Assessment Tool 5
Manual ocular function measurement conducted only if electronic version on device fails
University of Arkansas
Fayetteville, Arkansas, United States
University of Connecticut
Storrs, Connecticut, United States
University of Miami
Miami, Florida, United States
Michigan State University
East Lansing, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
INOVA Health System
Fairfax, Virginia, United States
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.
Time frame: 18 months for data acquisition
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
Time frame: 18 months for data acquisition
Identification of concussion subtypes
Validation of subtypes (at time of injury) with different clinical characterizations and outcome (e.g., rapid versus prolonged recovery).
Time frame: 18 months for data acquisition
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