Protocol Number: 99-N-0122

Title:

PET Imaging of Serotonin Receptors in Seizure Disorders

Number:

99-N-0122

Summary:

Patients in this study will undergo PET scans (a type of nuclear imaging test) to look for abnormalities in certain brain proteins associated with seizures.

Studies in animals have shown that serotonin-a chemical messenger produced by the body-attaches to proteins on brain cells called 5HT1A receptors and changes them in some way that may help control seizures. There is little information on these changes, however. A new compound that is highly sensitive to 5HT1A, will be used in PET imaging to measure the level of activity of these receptors and try to detect abnormalities. Changes in receptor activity may help determine where in the brain the seizures are originating.

Additional PET scans will be done to measure the amount of blood flow to the brain and the rate at which the brain uses glucose-a sugar that is the brain's main fuel. Blood flow measurement is used to calculate the distribution of serotonin receptors, and glucose use helps determine how seizures affect brain function.

The information gained from the study will be used to try to help guide the patient's therapy and determine if surgery might be beneficial in controlling the patient's seizures.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

Patients will be in age ranges of 18 to 65.

Patients may be male or female. Female patients of child bearing potential will have a pregnancy test prior to the study to ensure that pregnant patients will not participate in the study. During the study, woman of child bearing potential must use a reliable method of birth control.

Three groups of patients will be scanned:

- 50 patients with EEg and clinical evidence for mesial temporal onset with either MRI findings of mesial temporal sclerosis (MTS) or dysplasia or normal MRI studies.

- 15 patients with apparent neocortical seizure foci.

- Ten normal controls will be included. Controls will be screened in the NINDS Clinical Epilepsy Section outpatient clinic, with physical examination, CBC urinalysis and blood chemistries. Controls with chronic illnesses, taking any medications, or who smoke will be excluded. They will be asked to abstain from alcohol for one week before the study.

EXCLUSION CRITERIA:

Patients younger than 18 years old will be excluded from the study.

Patients with a known treatable seizure etiology such as neoplastic or infectious disease will be excluded.

Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.

Patients with progressive neurologic disorders.

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

Patients with cancer.

Patients not capable of giving an informed consent.

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

Special Instructions: Currently Not Provided

Keywords:

Epilepsy

Temporal Lobe

Blood Flow

Metabolism

Localization

Recruitment Keywords:

None

Conditions:

Partial Epilepsy

Investigational Drug(s):

(O15) Water

(F18) Fluorodeoxyglucose

(F18) FCWAY

Investigational Device(s):

None

Contacts:

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

Citations:

Regional effects of sodium valproate on extracellular concentrations of 5-hydroxytryptamine, dopamine, and their metabolites in the rat brain: an in vivo microdialysis study

Evidence for the existence of 5-hydroxytryptamine receptors, which are not of the 5-HT2 type, mediating contraction of rabbit isolated basilar artery

Radioligands for brain 5-HT2 receptor imaging in vivo: why do we need them?

• 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 Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/14/2004