Herpes Virus-6 and Epilepsy
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|ClinicalTrials.gov Identifier: NCT00085683|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : March 4, 2008
This study will explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients. The virus is also thought possibly to interfere with neurotransmitters - chemicals that brain cells use to communicate with each other. This study will measure levels of two of these chemicals, GABA and glutamate, which are believed to play a role in the development of seizures.
Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control subjects 18 years of age and older may be eligible for this study. Control subjects may not be taking any medication on a regular basis. Epilepsy patients may take only phenytoin, carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a physical examination and blood tests.
Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar puncture (spinal tap).
Up to four teaspoons of blood are drawn through a needle in the arm for this study.
MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which time the subject can communicate with the technician.
For this test the subject sits upright or lies on his or her side with knees curled at the chest. A local anesthetic is injected at the lower back, and a needle is inserted in the space between the bones where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Collection of the fluid usually takes from 5 to 20 minutes.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||Human Herpesvirus-6 and Its Effect on the GABA/Glutamate Balance in the Cerebrospinal Fluid and in the Brain From Patients With Epilepsy|
|Study Start Date :||June 2004|
|Estimated Study Completion Date :||July 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085683
|United States, Maryland|
|National Institute of Neurological Disorders and Stroke (NINDS)|
|Bethesda, Maryland, United States, 20892|