Clinical trial NCT02367300: Validation Of TBI Detection System For Head Injured Patients
Official title: Validation Of Point-Of-Care TBI Detection System For Head Injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Lead sponsor: BrainScope Company, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 981
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: 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.
timeFrame: 30 days
measure: To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).
timeFrame: 30 days
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Emory University- Grady Hospital
state: Georgia
city: Baltimore
country: United States
facility: R Cowley Shock Trauma Hospital
state: Maryland
city: Detroit
country: United States
facility: Wayne State University - Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University - Sinai Grace Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: UT-Houston Health Science Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: BrainScope Company, Inc.
name: Douglas C Oberly
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.