Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01793532
Eligibility Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01793532
Study Brief:
Protocol Section:
NCT01793532