Relationship of HHV-6B Virus to Seizures and Brain Injury

Terminated

• Conditions: Epilepsy; HHV6B Infection

• Registration Number: NCT00597285
• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

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.

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 Timeline

• Study Start: 2008-01-03
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Status Verified: 2013-11-01
• Study Completion: 2013-11-01
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of evidence for HHV6 infection in CSF

Secondary Outcome Measures

Name	Time	Method
Detection of lesions on 7T compared to 3T MRI

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States