Human Herpesvirus-6 and Its Effect on the GABA/Glutamate Balance in the Cerebrospinal Fluid and in the Brain From Patients With Epilepsy
Colección de datos
Enfermedades del Sistema Nervioso Central+1
+ Epilepsia
+ Enfermedades del Cerebro
Resumen
Fecha de inicio: 1 de junio de 2004
Fecha en la que se inscribió al primer participante.Objective: We would like to demonstrate with this study that the human herpesvirus-6 plays a role in the development of mesial temporal sclerosis (MTS) resulting in epilepsy. We would also like to examine what influence the virus has on the neurotransmitters glutamate and GABA, since we believe that an imbalance of the major excitatory and inhibitory neurotransmitters plays an important role in epilepsy. Study population: The study population will consist of adult patients with epilepsy and MTS and adult patients with epilepsy and no MTS as confirmed on magnetic resonance (MR) imaging scan of the brain. We will compare findings in these two groups to those in healthy adult volunteers. Design: This is a natural history study in which we will demonstrate the presence or absence of human herpesvirus-6 in the serum and cerebrospinal fluid (CSF) obtained from each of three adult study groups: patients with epilepsy and MTS, patients with epilepsy and no MTS, and normal controls. We will measure in all three groups the concentration of GABA and glutamate in CSF. In all three groups we will perform proton MR spectroscopy to non-invasively measure these metabolites in the brain. Outcome measures: The three subject groups will be compared in terms of the presence or absence of the human herpesvirus-6 in the serum and CSF and in terms of the levels of glutamate and GABA as measured in the CSF and by magnetic resonance spectroscopy of the hippocampus and temporal lobe.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 45 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Subjects of any race or ethnicity will be included in the study. Any subject who has been diagnosed with medically intractable epilepsy and is eligible for the epilepsy protocol #01-N-0139 will be evaluated for entry into this study. INCLUSION CRITERIA: * All patients will have a seizure disorder as documented by EEG and video-EEG. Half of the patients will have radiologically documented mesial temporal sclerosis and the other half will have a brain MRI without mesial temporal sclerosis. The patients can only be on phenytoin, carbamazepine, oxcarbazepine, lamotrigine or levetiracetam, since these anti-epileptic drugs have the least or no effect on the glutamate and GABA levels in the brain. The patients can not take any other medications. * Healthy control subjects entering the study must be free of serious disease as determined by a standard physical and neurological examination. The control subjects can not be on any medication. * All subjects must be able to give informed consent allowing us to use the cerebrospinal fluid and serum for research. * All subjects will have to be able to refrain from chocolate, tea and coffee (low monoamine diet; Wood et al.1979) and alcohol during the one week before the study. * Patients must be seizure free for 48 hours prior to the lumbar tap and the MRS. EXCLUSION CRITERIA Subjects will be excluded if: * They are under the age of 18 * They are female and are pregnant * They have a history of medical disorders which can affect the concentration of cerebral metabolites, including diabetes mellitus, renal dysfunction, hepatic dysfunction and electrolyte abnormality * They take any medication for the normal control group * They take any medication, with the exception of phenytoin, carbamazepine, oxcarbazepine, lamotrigine and levetiracetam for the epilepsy patients * They have a history of psychiatric and/or mood disorders * They have implanted devices such as pacemakers, medication pumps or defibrillators, or metal in the cranium except for the mouth, intra-cardiac lines, a history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI * They have a coagulopathy that prevents them from having a lumbar puncture performed * They have had a seizure 48 hours prior to the MRS and the lumbar tap Subjects who cannot give informed consent allowing us to use the removed fluid for research will also be excluded.
Centros del Estudio
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