Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001932
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Serotonin Receptors in Seizure Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Imaging of Serotonin Receptors in Seizure Disorders
Status:
COMPLETED
Status Verified Date:
2007-08-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 brains 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 patients therapy and determine if surgery might be beneficial in controlling the patients 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 brains 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 patients therapy and determine if surgery might be beneficial in controlling the patients seizures
Detailed Description:
Objective to study serotonin receptors in patients with localization-related epilepsy Studies in experimental animals have suggested that Serotonin is an anticonvulsant neurotransmitter in a number of seizure models its anticonvulsant action is mediated by activation of 5-HT1A receptors drugs with antiepileptic effects may release 5HT or block reuptake and these mechanisms appear to be related to their therapeutic effect 5HT1A receptors are abundant in regions such as entorhinal cortex hippocampus and temporal neocortex where epileptogenic zones are frequently found Considerable evidence from literature indicates that alterations in 5-HT1A receptors exist in experimental models of both generalized and complex partial seizures There is little data on changes in 5-HT receptors in epileptic patients
Study population 75 patients with localization-related epilepsy and 20 normal controls aged 18-60
Design Using a new PET compound which is a highly selective 5-HT1A silent antagonist referred to as 18FCWAY we will attempt to detect abnormalities in serotonin receptors in vivo in patients with epilepsy The patients will have 18FCWAY serotonin receptor studies which include 15H2O-CBF PET and high resolution T1-weighted MRI for co-registration 18FDG-PET will be performed in the patients as part of seizure focus localization We will also test subjects for the serotonin transporter polymorphism associated with depression and perform a standard depression battery
Outcome measures 5HT-1A receptor binding and Glucose metabolism measured by PET
Study population 75 patients with localization-related epilepsy and 20 normal controls aged 18-60
Design Using a new PET compound which is a highly selective 5-HT1A silent antagonist referred to as 18FCWAY we will attempt to detect abnormalities in serotonin receptors in vivo in patients with epilepsy The patients will have 18FCWAY serotonin receptor studies which include 15H2O-CBF PET and high resolution T1-weighted MRI for co-registration 18FDG-PET will be performed in the patients as part of seizure focus localization We will also test subjects for the serotonin transporter polymorphism associated with depression and perform a standard depression battery
Outcome measures 5HT-1A receptor binding and Glucose metabolism measured by PET
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-N-0122 | None | None | None |