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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BrainScope Company, Inc.
ClinicalTrials.gov Identifier:
NCT01556711
First received: March 5, 2012
Last updated: December 7, 2013
Last verified: December 2013
  Purpose

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


Condition
Brain Injuries
Craniocerebral Trauma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology

Resource links provided by NLM:


Further study details as provided by BrainScope Company, Inc.:

Primary Outcome Measures:
  • Structural Brain Injury Assessment [ Time Frame: within 24 hours of injury ] [ Designated as safety issue: No ]

    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 [ Time Frame: within 24 hours of injury ] [ Designated as safety issue: No ]
    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.


Enrollment: 816
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556711

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

Publications:
Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT01556711     History of Changes
Other Study ID Numbers: B-AHEAD II Trial
Study First Received: March 5, 2012
Last Updated: December 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by BrainScope Company, Inc.:
Head Injury
Head Trauma
TBI (Traumatic Brain Injury)
Emergency Department

Additional relevant MeSH terms:
Brain Injuries
Craniocerebral Trauma
Emergencies
Brain Diseases
Central Nervous System Diseases
Disease Attributes
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014