Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology

Brain Injuries Clinical Trial

— B-AHEAD II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556711
• Other study ID #: B-AHEAD II Trial
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: December 7, 2013
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: BrainScope Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 816
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Craniocerebral Trauma
• Emergencies

Locations

Country	Name	City	State
United States	Sinai Hospital	Baltimore	Maryland
United States	University of Maryland R Cowley Shock Trauma Center	Baltimore	Maryland
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Wayne State University - Detroit Receiving Hospital	Detroit	Michigan
United States	Wayne State University - Sinai Grace Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	INOVA Health System	Fairfax	Virginia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Hartford Hospital	Hartford	Connecticut
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 (4)

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. — View 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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No