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

Sponsor

BrainScope Company, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01556711

Collaborator

(none)

816

Enrollment

Locations

Duration (Months)

74.2

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

816 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Structural Brain Injury Assessment [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).

Secondary Outcome Measures

Functional Brain Injury Assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States	06102-5037
2	University of Maryland R Cowley Shock Trauma Center	Baltimore	Maryland	United States	21204
3	Sinai Hospital	Baltimore	Maryland	United States	21215
4	Wayne State University - Detroit Receiving Hospital	Detroit	Michigan	United States	48201
5	Wayne State University - Sinai Grace Hospital	Detroit	Michigan	United States	48235
6	Washington University - Barnes Jewish Hospital	St. Louis	Missouri	United States	63110
7	University of Rochester Medical Center	Rochester	New York	United States	14620
8	Duke University Medical Center	Durham	North Carolina	United States	27710
9	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
10	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908-2877
11	INOVA Health System	Fairfax	Virginia	United States	22042

Sponsors and Collaborators

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