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

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点分布在 1 个国家目标入组 700 人2014年3月11日

适应症Epilepsy

干预措施MEG MRI

概览

阶段: 不适用
干预措施: MEG
疾病 / 适应症: Epilepsy
发起方: National Institute of Neurological Disorders and Stroke (NINDS)
入组人数: 700
试验地点: 1
主要终点: All outcomes in this study are Exploratory.
状态: 招募中
最后更新: 18天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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 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.

详细描述

Objectives: The overall study objectives of this study are 1) to establish an age-stratified normative imaging database, 2) to explore the use of non-invasive imaging techniques such as morphometric analysis of structural MRI, resting state fMRI/EEG and resting state MEG/EEG to localize seizure foci. The sensitivities and specificities of analysis techniques will be determined based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, to explore the use of language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions, and to explore whether changes in resting state and task-based fMRI networks can be identified following epilepsy surgery, and how these changes relate to seizure and neuropsychological outcomes. Study population: 500 adults and children (age 8 and up) 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 1-4 MRI sessions during presurgical evaluation and additional 1-3 MRI sessions 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, neuropsychological testing, fMRI 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, with exploratory outcome measures of determination of comparison of the sensitivity and specificity of these measures to pre and postsurgical localization of the epileptogenic zone. Exploratory outcome measures include determination of the sensitivity and specificity of source localization using morphometric analysis of structural MRI, resting state MEG/EEG and resting state fMRI/EEG, evaluation of changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and post-surgically, and examination of the effects of epileptogenic activity and surgery on cognitive function and the networks underlying these functions.

注册库

clinicaltrials.gov

开始日期

2014年3月11日

结束日期

2028年3月30日

最后更新

18天前

研究类型

Observational

性别

All

研究者

发起方

National Institute of Neurological Disorders and Stroke (NINDS)

责任方

Sponsor

入排标准

入选标准

•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:

排除标准

•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)