NIH Clinical Research Studies

Protocol Number: 08-N-0027

Active Accrual, Protocols Recruiting New Patients

Title:
HHV6B in Epilepsy Imaging and CSF Studies
Number:
08-N-0027
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.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Patients with partial epilepsy.

Healthy controls up to age 45.

EXCLUSION CRITERIA:

Subjects unable or unwilling to undergo MRI and PET.

Subjects who have exceeded the NIH limits for radiation exposure for research purposes will have MRI alone.

Subjects with clear MRI lesions on standard clinical scans.

Subjects who are pregnant.

Special Instructions:
Currently Not Provided
Keywords:
18-F-Fluoro-2-Deoxy-D-Glucose (FDG)
Magnetic Resonance
Epilepsy
HHV-6B
Recruitment Keyword(s):
Epilepsy
Healthy Volunteer
HV
Condition(s):
Epilepsy
HHV6B Infection
Investigational Drug(s):
Fluorodeoxyglucose
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Neurological Disorders and Stroke

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8.

Begley CE, Famulari M, Annegers JF, Lairson DR, Reynolds TF, Coan S, Dubinsky S, Newmark ME, Leibson C, So EL, Rocca WA. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia. 2000 Mar;41(3):342-51.

Berg AT, Vickrey BG, Testa FM, Levy SR, Shinnar S, DiMario F, Smith S. How long does it take for epilepsy to become intractable? A prospective investigation. Ann Neurol. 2006 Jul;60(1):73-9.

Active Accrual, Protocols Recruiting New Patients

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