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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-N-0061

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 8
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Epilepsy;
MRI;
fMRI;
MEG

Recruitment Keyword(s)

None

Condition(s)

Epilepsy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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


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Citations:

Aghakhani Y, Bagshaw AP, B(SqrRoot)(Copyright)nar CG, Hawco C, Andermann F, Dubeau F, Gotman J. fMRI activation during spike and wave discharges in idiopathic generalized epilepsy. Brain. 2004 May;127(Pt 5):1127-44. Epub 2004 Mar 19.

Anderson JS, Ferguson MA, Lopez-Larson M, Yurgelun-Todd D. Reproducibility of single-subject functional connectivity measurements. AJNR Am J Neuroradiol. 2011 Mar;32(3):548-55. doi: 10.3174/ajnr.A2330. Epub 2011 Jan 27.

Ansari SF, Tubbs RS, Terry CL, Cohen-Gadol AA. Surgery for extratemporal nonlesional epilepsy in adults: an outcome meta-analysis. Acta Neurochir (Wien). 2010 Aug;152(8):1299-305. doi: 10.1007/s00701-010-0697-3. Epub 2010 Jun 4.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sara K. Inati, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10-CRC RM 7-5680
10 CENTER DR
BETHESDA MD 20814
(301) 435-6269
inatisk@mail.nih.gov

Aaliyah H. Hamidullah-Thiam
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5680
10 Center Drive
Bethesda, Maryland 20892
(301) 496-5121
aaliyah.hamidullahthiam@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02107989

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