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The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.
BrainScope One incorporates brain electrical activity (EEG, a proven electrophysiological core technology) and other multimodal assessment capabilities in a portable, point-of-care, non-invasive device containing algorithms designed to improve early identification, staging, and optimization of treatment for head injured patients (GCS 13-15) who are suspected of a brain injury. Structural Injury Classifier (SIC) provides objective results that indicate the likelihood of a structural brain injury being present, potentially visible on CT Scan. Brain Function Index (BFI) provides an objective measurement to determine the likelihood and severity of brain function impairment such as that seen in concussion/mTBI. The BFI is presented as a percentile compared to a normal corresponding population. Lastly, the Concussion Index (CI) was derived in the most recent BrainScope concussion assessment clinical study, and it is defined as a multivariate, multimodal index to assess the presence and severity of concussion and has been demonstrated to reliably reflect change over time.
The present study population targets those patients who sustained a head injury, have high GCS scores (14-15) and present mild symptoms, for whom the suspicion of structural brain injury is therefore low. Having a rapid, reliable, and sensitive assessment tool to aid in the triage of patients who are suspected of a traumatically induced structural brain injury could aid in appropriate and timely diagnosis and subsequent medical care. It may also result in more appropriate utilization of medical imaging (potentially having associated health risks) and reductions in hospitalizations. Patients discharged from the ED who were deemed to not require a CT scan will be followed-up for outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIC Negative | Subjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC negative group are those patients who obtain a 'Negative' result on the BrainScope One Structural Injury Classifier (SIC) algorithm. |
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| SIC Positive/Equivocal | Subjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC positive group are those patients who obtain a 'Positive' or 'Equivocal' result on the BrainScope One SIC algorithm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG Recording | Device | EEG recording acquired on BrainScope One device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical utility of integration of BSC SIC into the triage of closed head injured patients. | Demonstrate the accuracy of the BrainScope Structural Injury Classifier (SIC) negative findings through repeated follow ups of those patients discharged from the ED without receiving a CT scan, as determined by the ED physician. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative | For those who were BSC SIC negative and who are referred to CT due to clinician's decision, CT results will be obtained to assess the accuracy of BrainScope finding, this will allow an estimate of NPV. | After enrollment closure |
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Inclusion Criteria:
Exclusion Criteria:
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An estimated total of 660 patients (with target of 330 SIC negative patients) who are suspected of a traumatic, closed head injury within 3 days of injury, will be recruited from patients who enter the participating Hospital ED's as clinical sites for this study. Potential study subjects will be identified by the research staff based on the stated inclusion and exclusion criteria to determine their eligibility. Once identified, the research staff will recruit the subject for the study through an informed consent process. Participation in the study will not interfere with standard of care at the clinical sites.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie S Prichep, Ph.D. | BrainScope Company, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University - Detroit Receiving Hospital | Detroit | Michigan | 48201 | United States | ||
| Henry Ford Health System |
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| Neurocognitive Tests | Other | Cognitive performance tests performed on BrainScope One device. |
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| Clinician Evaluation | Other | Clinician evaluation performed as part of standard of care at the clinical site. |
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| 22-item CSI | Other | Self assessed 22-item Concussion Symptom Inventory (CSI). |
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| Higher specificity in BSC SIC compared to Nexus II and CCHR could result in decrease of referral for unnecessary CT scans due to higher specificity. |
Compare accuracy of Nexus II and CCHR Imaging rules to BrainScope in predicting true negatives |
| After enrollment closure |
| To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI) | The BFI/CI can help to inform the clinical decision on the likely of concussion at the time of injury in the ED environment and predict prolonged recovery. | After enrollment closure |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Wayne State University - Sinai Grace Hospital | Detroit | Michigan | 48235 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Beaumont Hospital | Troy | Michigan | 48085 | United States |
| Washington University - Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| El Paso Medical Center | El Paso | Texas | 79905 | United States |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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