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

Completed

Conditions studied: Brain Injuries, Craniocerebral Trauma

In brief

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

Key facts

Study ID

NCT01556711

Run by

BrainScope Company, Inc.

People needed

816

Starts

2012-08-01

Expected to finish

2013-09-01

Last updated by the study team

2013-12-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• University of Maryland R Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Sinai Hospital — Baltimore, Maryland, United States
• Wayne State University - Detroit Receiving Hospital — Detroit, Michigan, United States
• Wayne State University - Sinai Grace Hospital — Detroit, Michigan, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• INOVA Health System — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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