Relationship of HHV-6B Virus to Seizures and Brain Injury
HHV6B in Epilepsy Imaging and CSF Studies
This study will look for evidence that a virus called HHV-6B may be related to seizures and to a form of brain injury called mesial temporal sclerosis that is associated with seizures. The study will use new, more sensitive brain scans to try to detect brain regions that might be affected by the virus and will examine cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord) for evidence of the virus as well.
Healthy volunteers and people with seizures uncontrolled by anti-epileptic drugs who are between 18 and 45 years of age may be eligible for this study. Candidates are screened with a physical examination and laboratory tests.
Participants undergo the following procedures:
- PET scan. This test uses a radioactive chemical called 18FDG, which is detected by the PET scanner to obtain images of the brain. The subject lies on a table with his or her head positioned in the scanner. A swimming cap with a small light reflector is placed on the head to monitor the position of the head during the scan. A catheter (plastic tube) is inserted into an artery at the wrist or elbow crease of the arm for obtaining blood samples during the scan, and a second catheter is placed in a vein in the other arm for injecting the 18FDG. The scan takes up to 2 hours. A second scan may be done over an additional 15 minutes.
- MRI. This test uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies on a table that can slide in and out of a metal cylinder surrounded by a magnetic field. Most scans last between 45 and 90 minutes.
- Lumbar puncture. The subject sits upright or lies on a table with the knees curled to the chest for this procedure. A local anesthetic is injected to numb the skin and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.
- Blood tests. About 4 tablespoons of blood are drawn for viral tests.
Visão geral do estudo
Status
Condições
Descrição detalhada
Objectives: 1) to attempt to detect specific patterns of hippocampal injury in patients with temporal lobe epilepsy that may be associated with HHV-6B infection; 2) To attempt to detect evidence for persistent HHV6 infection in CSF in patients with refractory temporal lobe epilepsy. 3) to obtain preliminary pilot data on the ability of high resolution structural to detect abnormalities in epilepsy patients not seen with standard scanners.
Study Population: 45 patients with localization-related epilepsy; 45 healthy volunteers
Design: 1) imaging with a 7T MRI magnetic resonance scanner; 2) Lumbar puncture. 3) blood sampling
Main outcome measure: 1) Detection of evidence for HHV6 infection in CSF
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
Descrição
- INCLUSION CRITERIA:
Patients will be avaluated for participation under screening protocol 01-N-0139.
Patients
Male and female subjects age 18 to 55
Subjects with seizures uncontrolled by antiepileptic drugs
Subjects with no other illnesses, or taking other substances or medicines that could interfere with the study
Healthy Controls
Male and female subjects age 18 to 55.
EXCLUSION CRITERIA:
Patient
Subjects who are pregnant or breast feeding.
Subjects with any medical condition that could interfere with the study.
Subjects who are taking drugs that significantly reduce blood clotting such as Coumadin or Warfarin.
Healthy Volunteers
Subjects who are pregnant or breast feeding
Subjects who have any medical condition or be taking any substance or medication that could interfere with the study
Subjects who are taking drugs that significantly reduce blood cloting such as Coumadin or Warfarin
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Detection of evidence for HHV6 infection in CSF
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Medidas de resultados secundários
Medida de resultado |
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Detection of lesions on 7T compared to 3T MRI
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Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- Begley CE, Famulari M, Annegers JF, Lairson DR, Reynolds TF, Coan S, Dubinsky S, Newmark ME, Leibson C, So EL, Rocca WA. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia. 2000 Mar;41(3):342-51. doi: 10.1111/j.1528-1157.2000.tb00166.x.
- Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. doi: 10.1111/j.1528-1157.1997.tb04511.x.
- Berg AT, Vickrey BG, Testa FM, Levy SR, Shinnar S, DiMario F, Smith S. How long does it take for epilepsy to become intractable? A prospective investigation. Ann Neurol. 2006 Jul;60(1):73-9. doi: 10.1002/ana.20852.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
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
- 080027
- 08-N-0027
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