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Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy

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Qué se está recopilando

Colección de datos

Quiénes están siendo reclutados

Síndromes Epilépticos+4

+ Enfermedades del Sistema Nervioso Central

+ Epilepsia

A partir de 18 años
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Cómo está diseñado el estudio

Observacional
Inicio del estudio: abril de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Neurological Disorders and Stroke (NINDS)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 9 de abril de 2004

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Epilepsy surgery is emerging as a potent therapeutic intervention for a large group of patients with uncontrolled temporal lobe epilepsy, particularly when performed early in the course of the illness. Seizure freedom is an important goal of seizure surgery, but post-operative neuropsychological functioning is another equally important outcome measure. Both endpoints require careful pre-operative evaluation of the individual patient and better understanding of the functional neuroanatomy of the temporal lobe. In this study fMRI and DTI will be performed in patients with temporal lobe epilepsy and normal volunteers in an attempt to 1. investigate the role of the anterior temporal cortex in semantic processing, 2. evaluate the role of the amygdala in affective processing, 3. correlate the extent of white matter pathway resection with cognitive outcome after temporal lobectomy. STUDY POPULATION: We plan to study 30 patients with temporal lobe epilepsy (right-sided, left-sided seizure foci) pre and post temporal lobectomy as well as 30 normal volunteers. DESIGN: The study will be done in two parts both consisting of identical tasks. For the patient group part 1 will be performed prior to temporal lobectomy and part 2, 6-12 months after temporal lobectomy. For the normal volunteer group parts 1 and 2 will be performed at time interval of 6-12 months. During part 1 all study subjects will undergo neuropsychological evaluation. FMRI will be performed with two tasks: animal and tool naming (to evaluate semantic processing) and rating of emotionally pleasant or unpleasant pictures (to evaluate affective processing). All subjects will also undergo diffusion tensor imaging (DTI) for the visualization of white matter pathways. During part 2 of the study all of the above tests will be repeated. FMRI data will be analyzed within the framework of the general linear model in a program such as AFNI 2.5. Statistical comparisons between activation patterns in scans acquired during part 1 and part 2 within either group (intragroup comparison) will be done by voxel wise paired t-test. In a second analysis all 4 groups will be compared in a mixed model. The DTI data will be correlated with the neuropsychological outcome to asses the contribution of white matter abnormalities pre-operatively or severance of white matter pathways post-operative on neuropsychological functioning. OUTCOME PARAMETERS: Outcome parameters are changes in the fMRI activation pattern post temporal lobectomy and disruption of anisotropy on the diffusion tensor images.

Título OficialFunctional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy 
NCT00081432
Patrocinador PrincipalNational Institute of Neurological Disorders and Stroke (NINDS)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 20 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Síndromes EpilépticosEnfermedades del Sistema Nervioso CentralEpilepsiaEpilepsia del lóbulo temporalEnfermedades del CerebroEpilepsias ParcialesEnfermedades del sistema nervioso

Criterios

* INCLUSION CRITERIA: Patient Group: Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan. Native English speaker. Age 18 years or older. Signed informed consent. Volunteer Group: Native English speaker. Age 18 years or older. Signed informed consent. EXCLUSION CRITERIA: Patient Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc; History of mental retardation; Pregnancy; Claustrophobia; Inability to comply with the protocol. Volunteer Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.); History of neurologic or psychiatric disease or a learning or attention disorder or mental retardation. Pregnancy. Claustrophobia. Inability to comply with the protocol.

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesVer ubicación
Completado1 Centros de Estudio