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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 months for data acquisition |
| Identification of concussion subtypes |
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Inclusion Criteria:
For head injured subjects
For non-concussed head-injured controls
For matched controls and healthy volunteers
• GCS 15 at time of BrainScope assessment.
Exclusion Criteria:
For head injured subjects
For non-concussed head-injured controls
For matched controls and healthy volunteers
For healthy volunteers
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Male and female study subjects aged 13-50 from participating sites will be invited to enroll the study.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Prichep, Ph.D. | BrainScope Company, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Fayetteville | Arkansas | 72701 | United States | ||
| University of Connecticut |
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| SCAT5 | Diagnostic Test | Sports Concussion Assessment Tool 5 |
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| Near Point Convergence | Diagnostic Test | Manual ocular function measurement conducted only if electronic version on device fails |
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Validation of subtypes (at time of injury) with different clinical characterizations and outcome (e.g., rapid versus prolonged recovery).
| 18 months for data acquisition |
| Storrs |
| Connecticut |
| 06269 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| INOVA Health System | Fairfax | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000070642 | Brain Injuries, Traumatic |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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