Completado

Investigación de la Activación Funcional y el Acoplamiento Entre Regiones Cerebrales en Pacientes con Esquizofrenia, Sus Hermanos y Voluntarios Normales no Relacionados Utilizando EEG/MEG y fMRI

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Objetivo del estudio

Este estudio tiene como objetivo observar y comprender la activación funcional y el acoplamiento entre diferentes regiones cerebrales en individuos con esquizofrenia, sus hermanos y voluntarios sanos no relacionados, utilizando EEG/MEG y fMRI.

Qué se está recopilando

Colección de datos

Quiénes están siendo reclutados

Trastornos Mentales

+ Esquizofrenia

De 18 a 55 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Observacional
Inicio del estudio: septiembre de 1999
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Mental Health (NIMH)
Última actualización: 17 de diciembre de 2019
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 21 de septiembre de 1999

Fecha en la que se inscribió al primer participante.

It is the aim of this study to investigate the functional activation and coupling between brain regions in normals, patients with schizophrenia and unaffected family members. We will perform electrophysiological recordings (MEG, EEG) during cognitive activation (Continuous Performance Task, Sternberg paradigm, working memory). We will focus on the investigation of oscillatory brain activity as this is considered to be crucial for information processing related to neuronal integration. The measurements will be closely adapted to equivalent fMRI-measurements presented as an independent protocol (00-M-0085). The combination of both methods will help to improve activity source localization (MEG/EEG) and correlation of this activity between different parts of the brain. In addition, local activity patterns (fMRI) can be better characterized in the time domain (tonic versus phasic BOLD-activation). We will address whether cognitive activation goes along with an increase or decrease of correlation between regional brain areas. In this context, we will investigate whether this correlated activation pattern is different in schizophrenics and unaffected siblings when compared with normals. The study is integrated with the schizophrenia-sibling study (95-M-0150). Siblings of schizophrenic patients are investigated in order to achieve a better understanding of the genetic determination of schizophrenia-related pathophysiology.

NCT00001921
Patrocinador PrincipalNational Institute of Mental Health (NIMH)
Última actualización: 17 de diciembre de 2019
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 1386 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.

De 18 a 55 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

Trastornos MentalesEsquizofrenia

Criterios

INCLUSION CRITERIA: Controls: No psychiatric or severe chronic medical illness at the time of the study, and by history. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories and medical conditions that are judged not to interfere with the study may be allowed. No use of psychotropic substances in the last 3 months. There is no upper age limit the lower age limit is 18 years. Patients: 1) Schizophrenia, any subtype or schizoaffective disorder according to DSM IV, as detailed in protocol # 89-M-0160 ("Inpatient evaluation of neuropsychiatric inpatients", Dr. Jose Apud, principal investigator) and # 95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients", Dr. Daniel R. Weinberger, principal investigator). EXCLUSION CRITERIA: Controls and patients: Impaired hearing. Pregnancy (only for purpose of MRI procedures under separate protocols) Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. Patients or healthy volunteers with a known risk from exposure to high magnetic fields (e.g. patients with pace makers) and those who have metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans) will be excluded from participating in the fMRI studies. Patients: Coexistence of another major mental illness at the time of the study. If the patients experienced other mental illnesses in the past (e.g. a learning disability or major depression), then this should be judged to be fully recovered. Criteria for substance abuse met in the last 6 months. Criteria for substance dependence met in the last year. If criteria for dependence were met in the past, then the duration of the disorder was less than 3 years, or not judged to have produced long-term brain changes to allow the patient to be in the study. Major concurrent medical illness likely to interfere with the acquisition of the task. Concomitant medications which could interfere with performance on the task. Presence of dyskinetic movements of the face and tongue (likely to interfere with eyeblink measures), or of gross involuntary movements of the whole body (likely to interfere with positioning in the MRI scanner).

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesAbrir National Institutes of Health Clinical Center, 9000 Rockville Pike en Google Maps
Completado1 Centros de Estudio