Clinical trial NCT01556711: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Craniocerebral Trauma
Keywords: Head Injury
Head Trauma
TBI (Traumatic Brain Injury)
Emergency Department
Lead sponsor: BrainScope Company, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who enter the ED at hospitals that are participating as clinical sites for this study

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.

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

Primary outcomes:
measure: Structural Brain Injury Assessment
timeFrame: within 24 hours of injury
Secondary outcomes:
measure: Functional Brain Injury Assessment
timeFrame: within 24 hours of injury
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland R Cowley Shock Trauma Center
state: Maryland
city: Baltimore
country: United States
facility: Sinai 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: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Fairfax
country: United States
facility: INOVA Health System
state: Virginia
Study officials:
affiliation: Brooke Army Medical Center
name: Robert A De Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooke Army Medical Center
name: Peter Cuenca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland R. Cowley Shock Trauma Center
name: Samuel M Galvagno, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Medical Center
name: Stephen J Huff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University - Barnes Jewish Hospital
name: Rosanne Naunheim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University - Detroit Receiving Hospital
name: Brian O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University - Sinai Grace Hospital
name: Brian J O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hartford Hospital
name: Sandeep Johar, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Cetner
name: Bradley Kolls, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Jeffrey Bazarian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Fairfax Hospital
name: James Ecklund, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Hospital
name: Kevin Crutchfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.
citation: 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.