Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department
NCT ID: NCT02367274
Last Updated: 2016-04-19
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
421 participants
OBSERVATIONAL
2015-01-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* In addition,
* subjects with dementia,
* Parkinson's Disease,
* multiple sclerosis,
* seizure disorder,
* brain tumors,
* history of brain surgery,
* psychiatric disorder being managed by a psychiatric healthcare professional/provider,
* 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.
18 Years
85 Years
ALL
No
Sponsors
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BrainScope Company, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas C Oberly
Role: PRINCIPAL_INVESTIGATOR
BrainScope Company, Inc.
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Emory University- Grady Hospital
Atlanta, Georgia, United States
R Cowley Shock Trauma 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
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
UT-Houston Health Science Center
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Countries
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References
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Huff JS, Jahar S. Differences in interpretation of cranial computed tomography in ED traumatic brain injury patients by expert neuroradiologists. Am J Emerg Med. 2014 Jun;32(6):606-8. doi: 10.1016/j.ajem.2014.03.010. Epub 2014 Mar 18.
Prichep LS, Naunheim R, Bazarian J, Mould WA, Hanley D. Identification of hematomas in mild traumatic brain injury using an index of quantitative brain electrical activity. J Neurotrauma. 2015 Jan 1;32(1):17-22. doi: 10.1089/neu.2014.3365.
O'Neil B, Naunheim R, DeLorenzo R. CT positive brain injury in mild TBI patients presenting with normal SAC scores. Mil Med. 2014 Nov;179(11):1250-3. doi: 10.7205/MILMED-D-13-00585.
Prichep LS, Jacquin A, Filipenko J, Dastidar SG, Zabele S, Vodencarevic A, Rothman NS. Classification of traumatic brain injury severity using informed data reduction in a series of binary classifier algorithms. IEEE Trans Neural Syst Rehabil Eng. 2012 Nov;20(6):806-22. doi: 10.1109/TNSRE.2012.2206609. Epub 2012 Jul 26.
Prichep LS, Ghosh Dastidar S, Jacquin A, Koppes W, Miller J, Radman T, O'Neil B, Naunheim R, Huff JS. Classification algorithms for the identification of structural injury in TBI using brain electrical activity. Comput Biol Med. 2014 Oct;53:125-33. doi: 10.1016/j.compbiomed.2014.07.011. Epub 2014 Aug 1.
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.
O'Neil B, Prichep LS, Naunheim R, Chabot R. Quantitative brain electrical activity in the initial screening of mild traumatic brain injuries. West J Emerg Med. 2012 Nov;13(5):394-400. doi: 10.5811/westjem.2011.12.6815.
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.
Hanley DF, Chabot R, Mould WA, Morgan T, Naunheim R, Sheth KN, Chiang W, Prichep LS. Use of brain electrical activity for the identification of hematomas in mild traumatic brain injury. J Neurotrauma. 2013 Dec 15;30(24):2051-6. doi: 10.1089/neu.2013.3062. Epub 2013 Nov 23.
Ayaz SI, Thomas C, Kulek A, Tolomello R, Mika V, Robinson D, Medado P, Pearson C, Prichep LS, O'Neil BJ. Comparison of quantitative EEG to current clinical decision rules for head CT use in acute mild traumatic brain injury in the ED. Am J Emerg Med. 2015 Apr;33(4):493-6. doi: 10.1016/j.ajem.2014.11.015. Epub 2014 Nov 20.
Other Identifiers
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11-Ahead
Identifier Type: -
Identifier Source: org_study_id
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