Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury

Brain Injuries Clinical Trial

Official title:

An Observational Clinical Study of the BrainScope® Ahead™ M-100 Hand Held Electroencephalogram in Emergency Department Patients With Head Injury (B-AHEAD UK Trial)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01430988
• Other study ID #: Ahead™ M-100 B-AHEAD UK
• Status: Terminated
• Phase: N/A
• First received: September 7, 2011
• Last updated: May 2, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: BrainScope Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Institute for Health Research
• Study type: Observational

Clinical Trial Summary

The purpose of the current study is proposed to prospectively assess how accurately the BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.

Description:

One million patients attend Emergency Departments (ED) with head injuries each year in the United Kingdom (UK) and Ireland. 150,000 of these patients will need hospital admission and one study estimates an incidence of 45-48% moderate or severe disability in those surviving admission. Although the incidence of head injury is high, the incidence of death from head injury is low. Therefore ED's are required to see a large number of patients with a minor/mild head injury, and identify the very small number of these that will go on to have serious complications. The challenge to the emergency medicine clinician is identifying which patients with a head injury have an important brain injury that requires further attention and which patients can be safely sent home. The standard for determining an important brain injury is the result on the Computerised Tomography (CT) scan of the head. CT scanning is nonportable and exposes individuals to high radiation levels.

The study medical device is a portable, point of care, noninvasive and non radiation-emitting medical device designed to assist clinicians in early identification, staging, and optimisation of treatment for patients who are head injured.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 318
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• 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 'head injured' control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED and are suspected or who have sustained a head injury but do not report or manifest symptoms, e.g. facial lacerations and/or whiplash.

• 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 Road Traffic Accident requiring an ED visit or TBI within the last 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 tumours, history of brain surgery, 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 100 degrees F or 37.7 degrees C, current condition is listed as "critical", 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, anaesthetic, 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 Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Salford Royal Hospital	Salford	Manchester
United Kingdom	Royal London Hospital	Whitechapel	London

Sponsors (1)

Lead Sponsor	Collaborator
BrainScope Company, Inc.

Country where clinical trial is conducted

United Kingdom, 

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 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.	Within 24 hours of head injury	No
Secondary	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.	Within 24 hours of head injury	No