Ignite Creation Date:
2024-05-05 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 9:42 AM
Study NCT ID:
NCT00597285
Status:
TERMINATED
Last Update Posted:
2019-12-16
First Post:
2008-01-08
Brief Title:
Relationship of HHV-6B Virus to Seizures and Brain Injury
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
HHV6B in Epilepsy Imaging and CSF Studies
Status:
TERMINATED
Status Verified Date:
2013-11-01
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 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
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
Detailed Description:
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
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
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 |
|---|---|---|---|
| 08-N-0027 | None | None | None |