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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00706160
Eligibility Criteria:
* INCLUSION CRITERIA FOR PATIENTS:
1. Age 7-55
2. Documentation of localization-related epilepsy based on clinical, neuropsychological and imaging criteria
3. Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs
4. Willingness to be considered for surgery
5. Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker.
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
1. Age 7-55
2. Willingness to participate in and complete the study
3. Right-handedness assessed by the Edinburg handedness inventory
4. Fluency in English
EXCLUSION CRITERIA FOR PATIENTS:
1. Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
2. Claustrophobia or anxiety disorders exacerbated by the MRI scanner
3. People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies
4. Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning
5. Patients on phenobarbital or chronic benzodiazepines
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
1. Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel, permanent eyeliner, vagus nerve stimulator)
2. Any medical condition or chronic medication that might affect fMRI or MEG language activation by affecting cerebral structure or function, such as diabetes, hypertension, antihypertensive medications, psychotropic agents.
3. Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
55 Years
Study:
NCT00706160
Study Brief:
Protocol Section:
NCT00706160