Viewing Study NCT00085683



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00085683
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2004-06-10

Brief Title: Herpes Virus-6 and Epilepsy
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Human Herpesvirus-6 and Its Effect on the GABAGlutamate Balance in the Cerebrospinal Fluid and in the Brain From Patients With Epilepsy
Status: COMPLETED
Status Verified Date: 2005-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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

Blood Draw

Up to four teaspoons of blood are drawn through a needle in the arm for this study

MRI

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

Lumbar Puncture

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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
04-N-0209 None None None