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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00610558
Eligibility Criteria:
Controls (20 Subjects):
Inclusion criteria:
* Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below).
Exclusion criteria:
* History of seizures, faints, or any unexplained blackouts.
* Use of neuroleptic medications or sedating doses of antianxiety or antidepressant drugs.
* They should not have a clear family history of epilepsy (first degree relatives).
* History of any substance abuse within the past 5 years.
* History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
* History of stroke without complete recovery of neurologic function.
* Pregnancy
* With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
* Inability to understand the consent. (standard form attached)
* Inability to speak fluent English. Note: the neuropsychological tests are standardized for English speakers. They are not all available in multiple languages. Since the scoring and norms are established for English speakers, simply translating them would still not make the testing norms and scoring applicable.
Juvenile Myoclonic Epilepsy (JME; 20 Subjects):
Inclusion Criteria:
* Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus
* History of myoclonic plus tonic-clonic or clonic-tonic-clonic seizures with or without absence seizures.
* EEG consistent with primary generalized epilepsy (\>/= 3 c/s generalized, frontal maximum, poly spike and wave; normal alpha)
Exclusion Criteria
* History of significant head injury (\> 30 min loss of consciousness)
* Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs
* History of any substance abuse within the past 5 years
* Presence of epileptogenic brain lesion on MRI (tumor, stroke, cortical congenital dysplasia, etc; excluding normal variants, mild subcortical white matter ischemic change, venous angiomas).
* EEG with focal epileptiform potentials or polymorphic slowing
* History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
* History of stroke without complete recovery of neurologic function.
* Pregnancy
* With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
* Inability to speak fluent English
Frontal Lobe Epilepsy (FLE; 20 Subjects):
Inclusion Criteria
* Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus:
* Seizure semiology (behavior) consistent with FLE
* Interictal EEG spikes consistent with FLE or
* Ictal video-EEG consistent with FLE
* Frontal lobe lesion of MRI
* Frontal hypometabolism on FDG-PET
Exclusion Criteria:
* Presence of seizure semiology, ictal EEG, interictal EEG, MRI or PET findings that are not consistent with a frontal lobe epilepsy focus.
* Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs
* History of any substance abuse within the past 5 years
* History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
* History of stroke without complete recovery of neurologic function.
* Pregnancy
* With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
* Absence of either a radial or ulnar arterial pulse
* Inability to speak fluent English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00610558
Study Brief:
Protocol Section:
NCT00610558