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

NCT00597285 | Terminated

• 2 other identifiers: 08002708-N-0027
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; HHV6B Infection

Keywords

18-F-Fluoro-2-Deoxy-D-Glucose (FDG); Magnetic Resonance; Epilepsy; HHV-6B; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Detection of evidence for HHV6 infection in CSF

Secondary Outcomes (1)

• Detection of lesions on 7T compared to 3T MRI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be avaluated for participation under screening protocol 01-N-0139.
• Patients
• Male and female subjects age 18 to 55
• Subjects with seizures uncontrolled by antiepileptic drugs
• Subjects with no other illnesses, or taking other substances or medicines that could interfere with the study
• Healthy Controls
• Male and female subjects age 18 to 55.

You may not qualify if:

• Patient
• Subjects who are pregnant or breast feeding.
• Subjects with any medical condition that could interfere with the study.
• Subjects who are taking drugs that significantly reduce blood clotting such as Coumadin or Warfarin.
• Healthy Volunteers
• Subjects who are pregnant or breast feeding
• 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 cloting such as Coumadin or Warfarin

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1111/j.1528-1157.1997.tb04511.x.

  PMID: 9092951 BACKGROUND

• 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. doi: 10.1111/j.1528-1157.2000.tb00166.x.

  PMID: 10714408 BACKGROUND

• 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. doi: 10.1002/ana.20852.

  PMID: 16685695 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• William H Theodore, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 18, 2008
• Study Start: January 3, 2008
• Study Completion: November 1, 2013
• Last Updated: December 16, 2019

Record last verified: 2013-11-01

Locations

US (1)