Noninvasive Pre-surgical Evaluation for Focal Epilepsy

This study is looking at different ways to use brain imaging to help doctors find where seizures start in people with focal epilepsy (seizures that begin in one area of the brain). Researchers are using MRI (Magnetic Resonance Imaging) and MEG (Magnetoencephalography), which are non-invasive scans, to compare how well these methods identify the seizure focus before and after surgery. The goal is to improve how doctors pinpoint these areas, which can lead to better surgical outcomes. The study also aims to understand how epilepsy and surgery affect thinking and memory. You may be eligible if you are 8 years or older, have focal epilepsy, and are being evaluated for epilepsy surgery.

Study design
This is an observational study involving 700 participants, including 500 adults and children with uncontrolled focal epilepsy, and 200 healthy volunteers. It is a retrospective and prospective natural history study.
What's involved
If you are a patient, you would have 1-4 MRI sessions during your pre-surgical evaluation and an additional 1-3 MRI sessions about 12 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Patients will have additional MRI sessions approximately 12 months post-operatively.

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NCT02107989

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

Recruiting
Not specifiedAges 8+Observational
National Institute of Neurological Disorders and Stroke (NINDS)
~700 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:MRIMEG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All outcomes in this study are Exploratory.
Measured over All outcomes in this study are Exploratory.
Epilepsy
1 sites across 1 states
Maryland1
  • Sara K Inati, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

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Eligibility criteria

Inclusion

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).
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
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

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
Not able or willing to give consent or do not have an appropriate surrogate who can provide consent
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
  • All outcomes in this study are Exploratory.All outcomes in this study are Exploratory.

    All outcomes in this study are Exploratory.