Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology (B-AHEAD II)

Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology

The objectives of the study are to document device performance with respect to the primary and secondary endpoints.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Craniocerebral Trauma

Detailed Description

The purpose of the current study is proposed to prospectively validate the BrainScope Ahead® M-100 device design, performance, and labeling with respect to the device's target intended use and indications for use:

• 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.

• Study Type: Observational
• Enrollment (Actual): 816

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102-5037
      • Hartford Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital
    • Baltimore, Maryland, United States, 21204
      • University of Maryland R Cowley Shock Trauma Center
  • Michigan
    • Detroit, Michigan, United States, 48235
      • Wayne State University - Sinai Grace Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State University - Detroit Receiving Hospital
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University - Barnes Jewish Hospital
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234-6200
      • Brooke Army Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908-2877
      • University of Virginia Medical Center
    • Fairfax, Virginia, United States, 22042
      • Inova Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who enter the ED at hospitals that are participating as clinical sites for this study

Description

Inclusion Criteria:

• Males and females ages 18 to 80 (the entire age range), who are admitted to the Emergency Department (ED), who are suspected of a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury, as a result of insult to the head from an external force, e.g., the head being struck by an object, the head striking an object, the head being exposed to forces generated from a blast or explosion, and/or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head with a Glasgow Coma Scale of > 8.

  • 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:

• 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, 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural Brain Injury Assessment	Using a BrainScope classification algorithm, the Ahead® M-100 will identify subjects showing sensitivities among 3 classes: Green - brain electrical activity that is consistent with patients without head injuries (Ahead® M-100 output = 1), Yellow - brain electrical activity that is consistent with head injured subjects who are abnormal, but do not have a structural brain injury (Ahead® M-100 output = 2 or 3), Red - brain electrical activity consistent with a structural brain injury observable on CT (Ahead® M-100 output = 4).	within 24 hours of injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Brain Injury Assessment	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 the BrainScope Clinical Charter Patients classified as Yellow (b) will exhibit brain electrical activity consistent with more severe brain functional impairment. Patients classified as Yellow (a) will exhibit brain electrical activity consistent with less severe brain functional impairment observable by an evaluation of the functions on the flow chart.	within 24 hours of injury

Collaborators and Investigators

• Sponsor: BrainScope Company, Inc.
• Investigators: Principal Investigator: Robert A De Lorenzo, MD, Brooke Army Medical Center; Principal Investigator: Peter Cuenca, MD, Brooke Army Medical Center; Principal Investigator: Samuel M Galvagno, DO, University of Maryland R. Cowley Shock Trauma Center; Principal Investigator: Stephen J Huff, MD, University of Virginia Medical Center; Principal Investigator: Rosanne Naunheim, MD, Washington University - Barnes Jewish Hospital; Principal Investigator: Brian O'Neil, MD, Wayne State University - Detroit Receiving Hospital; Principal Investigator: Brian J O'Neil, MD, Wayne State University - Sinai Grace Hospital; Principal Investigator: Sandeep Johar, DO, Hartford Hospital; Principal Investigator: Bradley Kolls, MD, Duke University Medical Cetner; Principal Investigator: Jeffrey Bazarian, MD, University of Rochester; Principal Investigator: James Ecklund, MD, Inova Fairfax Hospital; Principal Investigator: Kevin Crutchfield, MD, Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (ESTIMATE): March 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 7, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Emergency Department; TBI (Traumatic Brain Injury); Head Trauma; Head Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Trauma, Nervous System; Emergencies; Brain Injuries; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: B-AHEAD II Trial