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

• ClinicalTrials.gov Identifier: NCT01556711
• Recruitment Status: Completed
• First Posted: March 16, 2012
• Last Update Posted: December 10, 2013
• Sponsor: BrainScope Company, Inc.
• Information provided by (Responsible Party): BrainScope Company, Inc.

Tracking Information

• First Submitted Date: March 5, 2012
• First Posted Date: March 16, 2012
• Last Update Posted Date: December 10, 2013
• Study Start Date: August 2012
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2012)

Structural Brain Injury Assessment [ Time Frame: within 24 hours of injury ]

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 15, 2012)

Functional Brain Injury Assessment [ Time Frame: within 24 hours of injury ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
• Official Title: Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology
• Brief Summary: The objectives of the study are to document device performance with respect to the primary and secondary endpoints.

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
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients who enter the ED at hospitals that are participating as clinical sites for this study

Condition

• Brain Injuries
• Craniocerebral Trauma

• Intervention: Not Provided

Study Groups/Cohorts

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2013): 816
• Original Estimated Enrollment (submitted: March 15, 2012): 750
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01556711
• Other Study ID Numbers: B-AHEAD II Trial
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: BrainScope Company, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: BrainScope Company, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: BrainScope Company, Inc.
• Verification Date: December 2013