Evaluating brain imaging techniques for patients with focal epilepsy
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
This study is testing different brain imaging methods to help find where seizures start in people with focal epilepsy who haven't responded to other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 8 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02107989 on ClinicalTrials.gov |
What this trial studies
This study aims to compare various non-invasive imaging techniques, such as structural MRI and resting state fMRI/EEG, to localize seizure foci in patients with medically refractory focal epilepsy. It will establish a normative imaging database using healthy volunteers and assess the effects of epileptogenic zones and surgery on cognitive functions. The study will involve both retrospective and prospective analyses, including neuropsychological testing and multiple MRI sessions for participants. The goal is to enhance the understanding of seizure localization and its impact on cognitive outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 8 and older with uncontrolled focal epilepsy who are being evaluated for epilepsy surgery.
Not a fit: Patients without focal epilepsy or those who do not meet the inclusion criteria for surgery evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the presurgical evaluation process for patients with focal epilepsy, leading to better surgical outcomes and cognitive function.
How similar studies have performed: Previous studies using similar imaging techniques have shown promise in improving seizure localization and understanding cognitive impacts, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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: * 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 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sara K Inati, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Aaliyah M HamidullahThiam
- Email: aaliyah.hamidullahthiam@nih.gov
- Phone: (301) 402-7686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.