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- Ensaio Clínico NCT02218216
TBI MR Study 3 Houston Methodist
Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Texas
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Neurological Institute
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Segment 1 (mTBI patient) Inclusion and Exclusion Criteria Inclusion Criteria for mTBI subjects
Subjects included in the main part of this study (Segment 1) will:
- Be aged ≥15 and ≤50 years old at the time of enrollment;
Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the first two intervals of the study, as follows:
- Meets criteria for enrollment in Encounter 1 (within 72 hours), or
- Meets criteria for enrollment in Encounter 2 (within 8±2 days)
- Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
Segment 1: Exclusion Criteria for mTBI subjects
Subjects will be excluded that have:
- Loss of consciousness (LOC) ≥15 minutes;
- Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;
- Diagnosis of moderate to severe TBI or GCS <13;
- Structural brain injury indicated by previous neuroimaging findings;
- Previous history of moderate to severe TBI;
- Any previous history of mild TBI within the past 12 months;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of self-reported illicit drug abuse (except marijuana) in past 10 years;
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix F - Screening for Exclusion based on Axis I or II Disorders):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
- Known structural brain disease or malformation;
- Current anti-psychotic or antiepileptic medication usage;
- That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
Contraindications to MRI scanning, including:
- Current or suspected pregnancy per site clinical practice;
- Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
- Inability to comply with any part of the site's MR safety policy.
Segment 2 (non-TBI subject) Inclusion and Exclusion Criteria Inclusion Criteria for Non-TBI subjects (Segment 2)
All included subjects will:
- Aged ≥15 and ≤50 years old at the time of enrollment;
Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:
- Age,
- Gender,
- Sociodemographic characteristics, and
- Handedness.
- Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
Exclusion Criteria for Non-TBI subjects (Segment 2)
Subjects will be excluded that:
- Are currently pregnant based on subject self-report of pregnancy status;
- Are currently enrolled in another Segment of this study;
- Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
- Prior diagnosis of mild TBI within the past 12 months;
- Have structural brain injury indicated by previous neuroimaging findings;
- Previous history of moderate to severe TBI within the past 10 years;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of illicit drug abuse (except marijuana) within the past 10 years
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix F - Screening for Exclusion based on Axis I or II Disorders):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
- Known structural brain disease or malformation;
- Current anti-psychotic or antiepileptic medication usage;
Have contraindications to MRI scanning, including:
- Current or suspected pregnancy per site clinical practice;
- Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
- Inability to comply with any part of the site's MR safety policy.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Experimental: Diagnóstico mTBI
Diagnóstico por ressonância magnética de indivíduos com lesão cerebral tramática leve (mTBI)
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Scanner de ressonância magnética disponível comercialmente usando bobinas de ressonância magnética investigativas ou padrão e uma série de pacotes de aplicativos investigativos contendo um conjunto predeterminado de sequências de pulsos de ressonância magnética
Outros nomes:
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Comparador de Placebo: Experimental: Diagnóstico Não mTBI
Diagnóstico de ressonância magnética de indivíduos não feridos que são compatíveis com mTBI
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Scanner de ressonância magnética disponível comercialmente usando bobinas de ressonância magnética investigativas ou padrão e uma série de pacotes de aplicativos investigativos contendo um conjunto predeterminado de sequências de pulsos de ressonância magnética
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progressão de mTBI indicada por características neurológicas clínicas, imagens de ressonância magnética e dados quantitativos de ressonância magnética de um novo software
Prazo: Linha de base até 3 meses
|
Para determinar associações entre dados neurológicos clínicos, imagens de RM, dados quantitativos de pós-processamento de software novo (software desenvolvido pelo patrocinador, incluindo volumetria, curtose, estado de repouso [RS], ressonância magnética funcional [fMRI] e módulos adicionais de pós-processamento podem ser oferecido
|
Linha de base até 3 meses
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph C Masdeu, MD. PhD, Houston Methodist Neurological Institute
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 (Real)
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
- 114-2014-GES-0046
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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