Validation Of TBI Detection System For Head Injured Patients

Brain Injuries Clinical Trial

— B-AHEAD III  

Official title:

Validation Of Point-Of-Care TBI Detection System For Head Injured Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367300
• Other study ID #: 22-Ahead
• Status: Completed
• Phase: N/A
• First received: February 12, 2015
• Last updated: June 17, 2016
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: BrainScope Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 981
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University- Grady Hospital	Atlanta	Georgia
United States	R Cowley Shock Trauma Hospital	Baltimore	Maryland
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Baylor University Medical Center	Dallas	Texas
United States	Wayne State University - Detroit Receiving Hospital	Detroit	Michigan
United States	Wayne State University - Sinai Grace Hospital	Detroit	Michigan
United States	Hartford Hospital	Hartford	Connecticut
United States	UT-Houston Health Science Center	Houston	Texas
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University - Barnes Jewish Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
BrainScope Company, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.	30 days	No
Secondary	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.		30 days	No
Secondary	To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).		30 days	No