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

NCT01556711 | Completed

• 1 other identifier: B-AHEAD II Trial
• Study Type: observational
• Target: 816
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Brain Injuries; Craniocerebral Trauma

Keywords

Head Injury; Head Trauma; TBI (Traumatic Brain Injury); Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Functional Brain Injury Assessment

  within 24 hours of injury

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BrainScope Company, Inc.: lead

Study Sites (11)

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

University of Maryland R Cowley Shock Trauma Center

Baltimore, Maryland, 21204, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Wayne State University - Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234-6200, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908-2877, United States

Location

INOVA Health System

Fairfax, Virginia, 22042, United States

Location

Related Publications (4)

• 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.

  PMID: 20825903 BACKGROUND

• 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.

  PMID: 20722504 BACKGROUND

• 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.

  PMID: 20223405 BACKGROUND

• 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.

  PMID: 20611046 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Craniocerebral Trauma; Brain Injuries, Traumatic; Emergencies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 16, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (11)