Completed

Positron Emission Tomography Measurement of Neuroinflammation in Focal Epilepsy

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+5

+ Central Nervous System Diseases

+ Nervous System Diseases

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2012
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 5, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: July 31, 2012

Actual date on which the first participant was enrolled.

Objectives: To study the role of inflammation in focal epilepsy To characterize the BBB state in patients with focal epilepsy using MRI, and compare the results with PET imaging of inflammation To study test-retest replicability of [11C]PBR28 PET scanning. Study population: 50 participants with drug-resistant focal epilepsy, 25 participants with drug-responsive focal epilepsy and 25 healthy volunteers. Design: Screening of enrolled participants will include a medical history, physical exam, and blood and urine laboratory testing. Blood samples will also be used for genetic polymorphism study. Healthy volunteers will receive one or two brain positron emission tomography (PET) scans with [11C]PBR28. Epilepsy participants will receive one or two PET scans with [11C]PBR28). Everyone will receive a brain magnetic resonance imaging (MRI). Some participants will also have a second MRI with gadolinium infusion to measure blood-brain barrier permeability. Outcome measures: The primary outcome measure will be the amount of differential [11C]PBR28 uptake between the epileptic focus and the homologous contralateral region. [11C]PBR28 distribution volume (VT) will be measured using an arterial input function. We want to quantify the tracer VT in regions of the brain distant from the epileptic focus, which may be affected by the disease. We hypothesize that focal epilepsy will be associated with brain inflammation and, therefore, that [11C]PBR28 uptake in the affected side of the brain will be higher than in the contralateral side. We will study the polymorphism of the translocator protein (TSPO), because TSPO polymorphism has an influence on [11C]PBR28 binding. This polymorphism is due to the non-conservative amino-acid substitution at position 147 from alanine to threonine (Ala147Thr) in the fifth transmembrane domain of the TSPO protein.

NCT01663545
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 5, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEpilepsyEpilepsies, PartialInflammation

Criteria

INCLUSION CRITERIA: For patients Age 18-60 Able to give written informed consent. Drug resistant participants will be defined as having clinically documented partial seizures with consistent EEG evidence as defined by the 2010 Revised terminology and concepts for organization of seizures and epilepsies and refractory to standard antiepileptic treatment for at least one year prior to enrolling in this study. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. Drug-responsive participants will be defined as having clinically documented partial seizures with consistent EEG evidence as defined by the 2010 Revised terminology and concepts for organization of seizures and epilepsies, seizure-free on standard antiepileptic treatment for at least three months prior to enrolling in this study. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. No prior diagnosis of drug or alcohol abuse or dependence. For healthy volunteers Age 18-60. Able to give written informed consent. No prior diagnosis of drug or alcohol abuse or dependence. EXCLUSION CRITERIA: For patients Previous research radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed the NIH RSC 5 rad per year research limit. Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine. History of brain disease other than epilepsy. Cannot lie on their back for at least two hours. Serious medical illness, other than epilepsy. Clinically significant laboratory abnormalities. Brain abnormality such as a brain tumor, infection, stroke, brain damage from head trauma or blood vessel abnormalities, on an MRI scan. Pregnancy or breast feeding. Able to get pregnant but does not use birth control. Risk for MRI scan, such as a pacemaker or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware. PBR28 non-binders. For drug-responsive subjects: occurrence of a seizure within the last three months. NIH employee or staff member For healthy volunteers Clinically significant laboratory abnormalities. Unable to have a MRI scan. History of neurologic illness or injury with the potential to affect study data interpretation. History of seizures, other than in childhood and related to fever. Previous research radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed the NIH RSC 5 rad per year research limit. Inability to lie flat on camera bed for at least two hours. PBR28 non-binders Pregnancy or breast feeding. Able to get pregnant but does not use birth control. NIH employee or staff member

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center