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- Ensaio Clínico NCT01430988
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
An Observational Clinical Study of the BrainScope® Ahead™ M-100 Hand Held Electroencephalogram in Emergency Department Patients With Head Injury (B-AHEAD UK Trial)
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Cambridge, Reino Unido, CB2 0QQ
- Addenbrooke's Hospital
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London
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Whitechapel, London, Reino Unido, E1 1BB
- Royal London Hospital
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Manchester
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Salford, Manchester, Reino Unido, M6 8HD
- Salford Royal Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Structural Injury Assessment
Prazo: Within 24 hours of head injury
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Functional Injury Assessment
Prazo: Within 24 hours of head injury
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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.
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Within 24 hours of head injury
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rupert Pearse, MD, Royal London Hospital, Barts and The London School of Medicine and Dentistry
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Ahead™ M-100 B-AHEAD UK
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Ensaios clínicos em Lesões cerebrais
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