💬In plain words
What the trial is, and whether it could suit you
Objectives:
The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions.
Study population:
300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers.
Design: A retrospective and prospective natural histor
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* INCLUSION CRITERIA FOR PATIENTS:
* Age 8 and older
* Evaluated or under evaluation for epilepsy surgery under protocol 18-N-0066,11-N-0051 or 16-N-0041
* Documentation of focal epilepsy based on MRI, EEG and/or ictal semiology
* Ability to give informed consent, have or be able to assign a legally authorized representative able to give consent (for adults without consent capacity), or parent/guardian able to provide informed consent (for a child).
INCLUSION CRITERIA FOR PATIENTS SOLELY CONTRIBUTING DATA:
* Had epilepsy surgery with presurgical evaluation under 18-N-0066
* Age 8 and up at the time of epilepsy surgery evaluation
* Had a preoperative structural brain MRI of the type used in this protocol
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
* Age 8 and older
* Ability to give informed consent or have a parent/guardian able to provide informed consent if a child.
* Ability to cooperate with MRI scanning without anesthesia
EXCLUSION CRITERIA FOR PATIENTS:
* Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants, shrapnel, permanent eyeliner)
* Claustrophobia or anxiety disorders exacerbated by the MRI scanner
* Pregnancy. All females of childbearing potential must have a negative pregnancy test prior to MRI scanning
EXCLUSION CRITERIA FOR PATIENTS SOLELY CONTRIBUTING DATA:
-Not able or willing to give consent or do not have an appropriate surrogate who can provide consent
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
* Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants, shrapnel, permanent eyeliner)
* Claustrophobia or anxiety disorders exacerbated by the MRI scanner
* Significant medical conditions that may affect the central nervous system, such as psychiatric disorders (such as mood disorders, psychotic disorders, substance abuse or dependence), significant neurologic disorders (such as brain injury, neurodegenerative disorders, multiple sclerosis, stroke, movement disorders, epilepsy), or active systemic disease that may affect the central nervous system (such as uncontrolled hypertension, autoimmune disorders or other inflammatory disorders, neoplastic disease)
* Use of centrally acting medications in the past 6 weeks, such as benzodiazepines, barbiturates, antidepressants, beta-blockers, and drugs for treating epilepsy or migraine
* Pregnancy. All females of childbearing potential must have a negative pregnancy test prior to MRI scanning
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