Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
NCT ID: NCT01556711
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
816 participants
OBSERVATIONAL
2012-08-31
2013-09-30
Brief Summary
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Detailed Description
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* Primary Endpoint:
* Structural Injury Assessment
* There are four co-primary endpoints in this study: two sets of sensitivity and specificity to divide the data into three classes.
* Using a BrainScope classification algorithm, the Ahead® M100 will identify subjects showing sensitivities among 3 classes: Green-normal, nonhead injured controls,Yellow-head injured subjects who do not exhibit brain electrical activity that is consistent with a structural brain injury observable on CT or for whom CT was not deemed necessary,Red-head injured subjects who exhibit brain electrical activity consistent with a structural brain injury observable by CT.
* Secondary Endpoint:
* Functional Injury Assessment
* There are two co-secondary endpoints for the secondary objective, the sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on a clinical charter used as the assessment of truth.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Head Injury
Males and females ages 18 to 80 (the entire age range), who are admitted to the ED, who are suspected of a traumatically induced structural brain
No interventions assigned to this group
Control
A 'normal' control group will be recruited for comparison and will consist of ED patients ("ED normal control group) who have sustained an injury but do not exhibit any trauma above the clavicle and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The acute, suspected traumatically induced structural brain injury and/or clinical manifestations of functional brain injury will have occurred within the past 24 hours upon admission to the ED.
* The ED normal control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED for presenting complaints that do not involve the head or neck (no trauma above the clavicles) and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope
Exclusion Criteria
* In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure disorder, brain tumors, history of brain surgery, mentally retarded, psychiatric disorder for which there is a prescribed psychiatric medication taken on a daily basis, 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 100oF or 37.7oC, current condition is listed as "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 (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist), subjects below the age of 18 years, pregnant women, and prisoners will not be eligible for study.
* ED normal control subjects will be excluded if there is a suspected neck injury or trauma above the clavicles, a primary complaint of generalized weakness, or a primary complaint of headache or migraine
18 Years
80 Years
ALL
No
Sponsors
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BrainScope Company, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert A De Lorenzo, MD
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center
Peter Cuenca, MD
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center
Samuel M Galvagno, DO
Role: PRINCIPAL_INVESTIGATOR
University of Maryland R. Cowley Shock Trauma Center
Stephen J Huff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Medical Center
Rosanne Naunheim, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University - Barnes Jewish Hospital
Brian O'Neil, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University - Detroit Receiving Hospital
Brian J O'Neil, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University - Sinai Grace Hospital
Sandeep Johar, DO
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital
Bradley Kolls, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical Cetner
Jeffrey Bazarian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
James Ecklund, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Fairfax Hospital
Kevin Crutchfield, MD
Role: PRINCIPAL_INVESTIGATOR
Sinai Hospital
Locations
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Hartford Hospital
Hartford, Connecticut, United States
University of Maryland R Cowley Shock Trauma Center
Baltimore, Maryland, United States
Sinai Hospital
Baltimore, Maryland, United States
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
INOVA Health System
Fairfax, Virginia, United States
Countries
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References
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Naunheim RS, Treaster M, English J, Casner T. Automated electroencephalogram identifies abnormalities in the ED. Am J Emerg Med. 2011 Oct;29(8):845-8. doi: 10.1016/j.ajem.2010.03.010. Epub 2010 May 1.
Naunheim RS, Treaster M, English J, Casner T, Chabot R. Use of brain electrical activity to quantify traumatic brain injury in the emergency department. Brain Inj. 2010;24(11):1324-9. doi: 10.3109/02699052.2010.506862.
Naunheim RS, Casner T. Novel method for detecting brain abnormality in a patient with epidural hematoma: a case report. Am J Emerg Med. 2010 Mar;28(3):386.e1-2. doi: 10.1016/j.ajem.2009.05.008.
McCrea M, Prichep L, Powell MR, Chabot R, Barr WB. Acute effects and recovery after sport-related concussion: a neurocognitive and quantitative brain electrical activity study. J Head Trauma Rehabil. 2010 Jul-Aug;25(4):283-92. doi: 10.1097/HTR.0b013e3181e67923.
Other Identifiers
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B-AHEAD II Trial
Identifier Type: -
Identifier Source: org_study_id