NCT00597285

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

Terminated Last updated 16 December 2019

What this trial tests

trial in Epilepsy in 33 participants. Terminated before completion.

Timeline

3 January 2008

1 November 2013

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	33
Start date	3 January 2008
Estimated completion	1 November 2013
Sites	1 location across United States

Conditions studied

• Epilepsy — all drugs for Epilepsy →
• HHV6B Infection — all drugs for HHV6B Infection →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 55, any sex, with Epilepsy or HHV6B Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.