Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database

  • STATUS
    Recruiting
  • End date
    Mar 30, 2028
  • participants needed
    500
  • sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
Updated on 15 September 2022
anesthesia
seizure
neuropsychological test
electroencephalogram
partial epilepsy
intractable epilepsy
epilepsy surgery
Accepts healthy volunteers

Summary

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 8-65) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers.

Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits.

Outcome measures:

The main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome measures will include determination of the sensitivity and specificity of source localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions.

Description

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 8-65) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers.

Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits.

Outcome measures:

The main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Exploratory outcome measures will include determination of the sensitivity and specificity of source localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre-and post surgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions.

Details
Condition Epilepsy
Treatment MRI, MEG
Clinical Study IdentifierNCT02107989
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last Modified on15 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 8-65 years old
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 or have 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 8-65 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 8-65 years old
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

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
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS
provide consent
Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants
Claustrophobia or anxiety disorders exacerbated by the MRI scanner
shrapnel, permanent eyeliner)
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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