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

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT02107989
Collaborator
(none)
500
1
2
168.6
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: MRI
  • Device: MEG
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
Actual Study Start Date :
Mar 11, 2014
Anticipated Primary Completion Date :
Mar 30, 2028
Anticipated Study Completion Date :
Mar 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: healthy volunteers

healthy volunteers

Device: MRI
MRI of the brain is routinely used to identify abnormal areas of cortex in patients with medically refractory epilepsy. MRI evaluations of brain may be performed at field strengths of 1.5T, 3T, and/or 7T, under conditions designated by the FDA as constituting nonsignificant risk.

Device: MEG
MEG/EEG: Magnetoencephalogra phy (MEG) is commonly used during epilepsy pre-surgical evaluations to help with localizing epileptic foci. MEG will be obtained as clinically indicated, usually in patients with unclear seizure focus localization who are undergoing presurgical evaluation, particularly when they have frequent interictal discharges on EEG. MEG records very small magnetic fields generated by the brain at rest, or in response to a task or to epileptic activity. Resting state MEG/EEG analysis will be used for research purposes only.

Experimental: Patients

Patients

Device: MRI
MRI of the brain is routinely used to identify abnormal areas of cortex in patients with medically refractory epilepsy. MRI evaluations of brain may be performed at field strengths of 1.5T, 3T, and/or 7T, under conditions designated by the FDA as constituting nonsignificant risk.

Device: MEG
MEG/EEG: Magnetoencephalogra phy (MEG) is commonly used during epilepsy pre-surgical evaluations to help with localizing epileptic foci. MEG will be obtained as clinically indicated, usually in patients with unclear seizure focus localization who are undergoing presurgical evaluation, particularly when they have frequent interictal discharges on EEG. MEG records very small magnetic fields generated by the brain at rest, or in response to a task or to epileptic activity. Resting state MEG/EEG analysis will be used for research purposes only.

Outcome Measures

Primary Outcome Measures

  1. All outcomes in this study are Exploratory. [All outcomes in this study are Exploratory.]

    All outcomes in this study are Exploratory.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • INCLUSION CRITERIA FOR PATIENTS:

  • 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

Sponsors and Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Sara K Inati, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT02107989
Other Study ID Numbers:
  • 140061
  • 14-N-0061
First Posted:
Apr 9, 2014
Last Update Posted:
Aug 19, 2022
Last Verified:
Jul 28, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022