Relationship of HHV-6B Virus to Seizures and Brain Injury
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Purpose
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.
| Condition |
|---|
|
Epilepsy HHV6B Infection |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | HHV6B in Epilepsy Imaging and CSF Studies |
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2008 |
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 and functional imaging 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) imaging with a high resolution PET scanner; 3) Lumbar puncture. 4) blood sampling
Main outcome measure: 1) Detection of evidence for HHV6 infection in CSF
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
Patients will be avaluated for participation under screening protocol 0-N-0139.
Patients
Subjects with seizures uncontrolled by antiepileptic drugs
Subjects with no other illnesses, or taking other substances or medicines, that could interfere with the study
Subjects who have not participated in other research studies whose exposure puts them over the radiation safety guidelines limit of 5 rems per year
Male and female subjects age 18 to 55
Healthy Controls
Subjects who have not participated in other research studies whose exposure puts them over the radiation safety guidelines limit of 5 rems per year.
Subjects who are not pregnant or breast feeding.
Subjects with any medical condition that could interfere with the study. Subjects who have had the maximum amount of radiation for research allowed in one year cannot have the high resolution PET scan, but may have the 7 Tesla MRI scan and lumbar puncture.
EXCLUSION CRITERIA:
Patient
Subjects who are pregnant or breast feeding.
Subjects with any medical condition that could interfere with the study.
Subjects who have had the maximum amount of radiation for research allowed in one year cannot have the high resolution PET scan, but may have the 7 Tesla MRI scan and lumbar puncture.
Subjects who are taking drugs that significantly reduce blood clotting such as Coumadin or Warfarin. Lumbar puncture is performed routinely on patients taking ASA therapy. All patients will have PT/PTT and platelets tested and will be excluded if results are abnormal. Subjects who are pregnant or breast feeding.
Healthy Volunteers
Subjects who have any medical condition or be taking any substance or medication that could interfere with the study.
Subjects who are taking drugs that significantly reduce blood clotting such as Coumadin or Warfarin. Lumbar puncture is performed routinely on patients taking ASA therapy. All patients will have PT/PTT and platelets tested and will be excluded if results are abnormal.
Contacts and Locations| Contact: Patricia M Reeves-Tyer, R. EEG T. | (301) 496-1923 | tyerp@ninds.nih.gov |
| Contact: William H Theodore, M.D. | (301) 496-1505 | theodore@ninds.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | William H Theodore, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00597285 History of Changes |
| Other Study ID Numbers: | 080027, 08-N-0027 |
| Study First Received: | January 8, 2008 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
18-F-Fluoro-2-Deoxy-D-Glucose (FDG) Magnetic Resonance Epilepsy |
HHV-6B Healthy Volunteer HV |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
