- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01712633
Tests of Functional Magnetic Resonance Imaging Techniques
Imaging Techniques in fMRI and fMRI Reproducibility: An NIH/FDA Interagency Collaboration
Background:
- Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series of pictures that can be used to look at how the brain processes information. It is used to study problems with thinking, language, and movement, among other things. Researchers are working to develop new and better fMRI techniques. To test these techniques, they want to perform fMRI scans on healthy volunteers.
Objectives:
- To test different fMRI techniques in healthy volunteers.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have fMRI scans of the brain. During these scans, they will be asked to perform simple tasks. These tasks may involve language, thinking, or motor skills. The scanning sessions will last up to 2 hours.
- Participants may be asked to return for additional fMRI scans over several years.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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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:
- Healthy volunteers, new or from current NIH protocols are eligible. Healthy volunteers will be defined according the history obtained from reported medical history, medical record (reported at registration), the MRI safety questionnaire, and a clinical grade noncontrast brain MRI.
- Willing to travel to the NIH for follow-up visits
- Greater than 18 years old
- Able to understand and sign informed consent.
- Bilingual or multilingual subjects can participate in this study as long as the subjects are also fluent in English. Subjects do not need to be native or monolingual speakers of English.
EXCLUSION CRITERIA:
The following criteria will be used to exclude subjects from participating in this protocol:
Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:
- Aneurysm clip, implanted neural stimulator,
- Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
- Cochlear implant, ocular foreign body (metal shavings),
- Any implanted device (pumps, infusion devices, etc.),
- Shrapnel injuries,
- History of metal in head or eyes or other parts of the body.
- Vagus Nerve Stimulators (VNS)
- Subjects with tattoos that contain metal.
- Pregnant women
- Over 350 lbs because of the weight limit of the MRI table
- Prior surgery that may render performing the MRI to be unsafe.
- Untreatable claustrophobia otherwise requiring anesthesia or antianxiety medications that may alter the subject s ability to perform the tasks during fMRI scanning.
- Subjects will be asked to refrain from drinking or eating caffeinated foods or drinks the morning of the scan that can result in vessel vasoconstriction prior to the scan.
- Any contraindications that the Physician identifies from the Subject s reported history, MRI Safety Questionnaire and/or medical record.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Volunteers
Healthy Volunteers
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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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evaluation of fMRI techniques
Prazo: Study day 1, followup visit(s)
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To test different fMRI techniques in healthy volunteers.
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Study day 1, followup visit(s)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nadia M Biassou, M.D., National Institutes of Health Clinical Center (CC)
Publicações e links úteis
Publicações Gerais
- Hennig J, Speck O, Koch MA, Weiller C. Functional magnetic resonance imaging: a review of methodological aspects and clinical applications. J Magn Reson Imaging. 2003 Jul;18(1):1-15. doi: 10.1002/jmri.10330.
- Bennett CM, Miller MB. How reliable are the results from functional magnetic resonance imaging? Ann N Y Acad Sci. 2010 Mar;1191:133-55. doi: 10.1111/j.1749-6632.2010.05446.x.
- Pillai JJ. The evolution of clinical functional imaging during the past 2 decades and its current impact on neurosurgical planning. AJNR Am J Neuroradiol. 2010 Feb;31(2):219-25. doi: 10.3174/ajnr.A1845.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Outros números de identificação do estudo
- 130003
- 13-CC-0003
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