Validation Of TBI Detection System For Head Injured Patients (B-AHEAD III)

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ClinicalTrials.gov Identifier: NCT02367300

Recruitment Status : Completed

First Posted : February 20, 2015

Last Update Posted : June 21, 2016

Sponsor:

Information provided by (Responsible Party):

BrainScope Company, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Brain Injuries	Device: BrainScope Ahead 200

Detailed Description:

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	981 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Validation Of Point-Of-Care TBI Detection System For Head Injured Patients
Study Start Date :	February 2015
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	January 2016

Groups and Cohorts

Intervention Details:

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.

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 30 days ]
The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.

Secondary Outcome Measures :

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. [ Time Frame: 30 days ]
To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+). [ Time Frame: 30 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects who are suspected of a traumatic, closed head injury within 72 hours will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study.

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367300

Locations

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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Georgia
Emory University- Grady Hospital
Atlanta, Georgia, United States, 30303
United States, Maryland
R Cowley Shock Trauma Hospital
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States, 48235
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States, 48235
United States, Missouri
Washington University - Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
UT-Houston Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

BrainScope Company, Inc.

Investigators

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Principal Investigator:	Douglas C Oberly	BrainScope Company, Inc.

More Information

Publications of Results:

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.

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.

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 Publications:

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.

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, Vodencarević 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hanley D, Prichep LS, Badjatia N, Bazarian J, Chiacchierini R, Curley KC, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright DW, Huff JS. A Brain Electrical Activity Electroencephalographic-Based Biomarker of Functional Impairment in Traumatic Brain Injury: A Multi-Site Validation Trial. J Neurotrauma. 2018 Jan 1;35(1):41-47. doi: 10.1089/neu.2017.5004. Epub 2017 Sep 21.

Hanley D, Prichep LS, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones EB, Wright DW, O'Neill J, Badjatia N, Gandhi D, Curley KC, Chiacchierini R, O'Neil B, Hack DC. Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial. Acad Emerg Med. 2017 May;24(5):617-627. doi: 10.1111/acem.13175. Epub 2017 Mar 31.

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Responsible Party:	BrainScope Company, Inc.
ClinicalTrials.gov Identifier:	NCT02367300
Other Study ID Numbers:	22-Ahead
First Posted:	February 20, 2015 Key Record Dates
Last Update Posted:	June 21, 2016
Last Verified:	June 2016

Additional relevant MeSH terms:

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Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases	Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries

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