Validation Of TBI Detection System For Head Injured Patients

Study Overview
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Brief Summary
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A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

Detailed Description
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The objective of this study is to validate the clinical utility of the BrainScope technology for the acute identification of structural brain injuries in a TBI population presenting to the ED with mild symptoms, following closed head injury.

Official Title
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Validation Of Point-Of-Care TBI Detection System For Head Injured Patients

Conditions
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Brain Injuries

Intervention / Treatment
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* Device: BrainScope Ahead 200


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 72 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury). Exclusion Criteria: Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin. In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure disorder, brain tumors, history of brain surgery, evidence of acute psychosis, substance dependence, history of TIA or stroke within the last year, currently receiving dialysis or in end-stage renal disease, active fever defined as greater than 100 degrees F or 37.7 degrees C, current condition is critical in the opinion of the investigator, subject is suffering from an open head injury, subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications. Subjects below the age of 18 years, and prisoners will not be eligible for study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BrainScope Ahead 200|A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury. | The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score. |  | 30 days | 
| To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+). |  | 30 days |