Protocol Number: 07-N-0103

Title:

Imaging Serotoninergic Neurotransmission in Epilepsy

Number:

07-N-0103

Summary:

This study will investigate the role that a brain chemical called serotonin plays in seizures. Serotonin, present naturally in the brain, helps transmit signals between nerve cells. Glucose is a sugar that is the main fuel of the brain. Studying these two chemicals may help explain why people with epilepsy get seizures and are more likely to be depressed.

Healthy volunteers and patients 18 to 60 years of age who have epilepsy with or without depression and whose seizures are not controlled by medication may be eligible for this study. Candidates are screened with a review of their medical history, a physical examination and an electroencephalogram (EEG, brain wave recording).

Participants undergo the following procedures:

-Positron emission tomography (PET) scans: The first of three PET scans measures brain blood flow and the activity at some of the brain serotonin receptors (the parts of brain cells to which serotonin attaches). A second scan measures the amount of serotonin transported between brain cells. A third scan measures glucose use. The PET scanner is shaped like a doughnut. The subject lies on a bed that slides in and out of the scanner with his or her head inside the opening. A special mask is fitted to the subject's head to help keep it still during the procedure so the images will be clear. For the first scan, catheters (plastic tubes) are placed in an arm vein to inject a radioactive substance and in an artery in the wrist to collect blood samples. The other two scans require only the catheter in the arm.

-Magnetic resonance imaging: This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. The subject lies on a table that can slide in and out of the cylinder. Most scans last between 45 and 90 minutes. Subjects wear earplugs to muffle loud knocking noises that occur during scanning.

-Psychological evaluation: Subjects are interviewed and fill out questionnaires to help study sadness and depression in epilepsy.

-Blood draw: Blood tests look for differences in genes between people with epilepsy who are depressed and those who are not.

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:

A. Patients must have clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard antiepileptic treatment for at least one year. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic, and if necessary, inpatient video-EEG monitoring.

B. Patients will be in age ranges 18 to 60.

C. Patients may be male or female.

EXCLUSION CRITERIA:

A. Patients younger than 18 or older than 60 years old. There is evidence for reduced 5HT(1A) receptor binding in elderly patients.

B. Patients with a known treatable seizure etiology such as neoplastic or infectious disease.

C. Patients with MRI findings consistent with brain tumors, trauma or AVMs.

D. Patients with progressive neurologic disorders.

E. Patients with a history of significant medical disorders or requiring chronic treatment with other drugs which can not be stopped, except for antidepressants.

E.1. Eligible patients on other antidepressants will be evaluated by NIMH for possible alterations in their regimen that would permit participation.

F. Patients with cancer.

G. Patients not capable of giving an informed consent.

H. Patients who had seizure activity 24 hours prior to the study.

I. Women who are pregnant or nursing.

J. Subjects who are current smokers may not participate, as smoking may affect serotoninergic neurotransmission.

K. Patients with coagulation abnormalities.

Special Instructions:

Currently Not Provided

Keywords:

Positron Emission Tomograhy (PET)

MRI (Magnetic Resonance Imaging)

Seizures

Temporal Lobe

Depression

Recruitment Keyword(s):

Epilepsy

Healthy Volunteer

HV

Condition(s):

Epilepsy

Investigational Drug(s):

18F-FCWAY

18F-FDG

15O-Water

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):

Bromfield EB, Altshuler L, Leiderman DB, Balish M, Ketter TA, Devinsky O, Post RM, Theodore WH. Cerebral metabolism and depression in patients with complex partial seizures. Arch Neurol. 1992 Jun;49(6):617-23.

Kanner AM. Depression in epilepsy: prevalence, clinical semiology, pathogenic mechanisms, and treatment. Biol Psychiatry. 2003 Aug 1;54(3):388-98.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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