Status:
COMPLETED
Study of [11C]DPA-713 for Temporal Lobe Epilepsy
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Epilepsy
Temporal Lobe
Eligibility:
All Genders
18+ years
Brief Summary
Background: \- Some people with epilepsy have an epileptic focus, a small part of the brain that is the starting point of the seizure. This focus is like an irritant or an inflammation, and helps cau...
Detailed Description
OBJECTIVE: Translocator protein 18 kDa (TSPO) is highly expressed in activated microglia and reactive astrocytes in brain, and it may, thereby, be a useful biomarker of neuroinflammation. We develope...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For healthy volunteers
- Age 18 or older.
- Able to give written informed consent.
- No prior diagnosis of drug or alcohol abuse or dependence.
- For patients
- Age 18 or older.
- Able to give written informed consent.
- Having clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, which may be refractory or responsive to standard antiepileptic treatment. 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.
- Negative toxicology testing at the time of screening.
- No prior diagnosis of drug or alcohol abuse or dependence.
- EXCLUSION CRITERIA:
- For healthy volunteers
- Any current Axis I diagnosis.
- Clinically significant laboratory abnormalities.
- Positive test for HIV.
- 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.
- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
- Inability to lie flat on camera bed for at least two hours.
- Pregnancy or breast feeding.
- Able to get pregnant but does not use birth control.
- Drug/alcohol abuse or dependence
- For patients
- Previous radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed NIH RSC research limits.
- 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.
- Known cause for seizures, other than mesial temporal sclerosis, such as tumor or infection.
- Serious medical illness, other than epilepsy.
- Clinically significant laboratory abnormalities.
- Positive test for HIV.
- Brain abnormality such as a brain tumor, 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.
- For drug-responsive subjects: occurrence of a seizure within the last three months.
- Drug/alcohol abuse or dependence
Exclusion
Key Trial Info
Start Date :
January 31 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2016
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01793532
Start Date
January 31 2013
End Date
June 8 2016
Last Update
December 16 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892