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

NCT01430988 | Terminated

• 1 other identifier: Ahead™ M-100 B-AHEAD UK
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Brain Injuries; Craniocerebral Trauma

Keywords

Head Injuries; Head Trauma; TBI (Traumatic Brain Injury); Emergency Department; Accident & Emergency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Functional Injury Assessment

  Within 24 hours of head injury

Study Arms (3)

Head Injured Group

Subjects 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 will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study

Normal Control Group

A normal control group will be recruited for comparison and will consist of Emergency Department patients who have sustained an injury but do not exhibit any trauma above the clavicle and no history of Road Traffic Accident requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope.

Head Injured Control Group

A 'head injured' control group will be recruited and will consist of Emergency Department patients who are suspected or who have sustained a head injury but do not report or manifest symptoms, e.g. facial lacerations and/or whiplash.

Eligibility Criteria

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

Study Population

Patients who present to the Emergency Department or Accident \& Emergency within the selected hospitals participating in the 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 '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.

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 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.

Sponsors & Collaborators

• BrainScope Company, Inc.: lead

Study Sites (3)

Addenbrooke's Hospital

Cambridge, Cambridge, CB2 0QQ, United Kingdom

Location

Royal London Hospital

Whitechapel, London, E1 1BB, United Kingdom

Location

Salford Royal Hospital

Salford, Manchester, M6 8HD, United Kingdom

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

• Rupert Pearse, MD

  Royal London Hospital, Barts and The London School of Medicine and Dentistry

  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: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

GB (3)