Evaluación prequirúrgica no invasiva de pacientes con epilepsia focal y establecimiento de una base de datos de imágenes normativas
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Sara K Inati, M.D.
- Número de teléfono: (301) 435-6269
- Correo electrónico: inatisk@mail.nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Aaliyah M HamidullahThiam
- Número de teléfono: (301) 435-2952
- Correo electrónico: aaliyah.hamidullahthiam@nih.gov
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- Reclutamiento
- National Institutes of Health Clinical Center
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
500 adults and children (age 8 and up) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers.
Descripción
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
healthy volunteers
healthy volunteers |
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. MEG/EEG: Magnetoencephalography (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. |
|
Patients
Patients |
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. MEG/EEG: Magnetoencephalography (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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All outcomes in this study are Exploratory.
Periodo de tiempo: All outcomes in this study are Exploratory.
|
All outcomes in this study are Exploratory. |
All outcomes in this study are Exploratory.
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Sara K Inati, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 140061
- 14-N-0061
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .