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Organization of the Cingulate Cortex (EEG-Feedback)

6 de julio de 2017 actualizado por: Hospices Civils de Lyon

Structure-function Relationships Within the Cingulate Cortex

Efficient evaluation and monitoring of actions and outcomes are a key feature of primates' efficient adaptive cognition. Deficits in evaluating one's own actions and their consequences is a key feature of prominent disorders such as obsessive compulsive disorders (OCD), schizophrenia, and anxiety. The Investigators know that these evaluative processes implicate medial structures of the brain that are related both to old limbic functions and to more recently evolved higher executive functions. Brain potentials related to performance monitoring have attracted a lot of interest in cognitive neuroscience but also in the clinical domain because they appear to be altered in different neurological or psychiatric disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of pathologies. But the neural sources of these markers are not fully determined and are currently highly debated. In addition, our work suggests that non pathological factors, such as normal morphological cortical variations, could affect those markers. Understanding performance monitoring, acting directly on medial cortex, or using electrophysiological markers in clinic are thus currently problematic and challenging. This is mostly because structure-function relationships in the medial wall are ill defined for historical, conceptual, and methodological reasons. Importantly, although individual variability of brain morphology impedes precise assessment of structure function relationships, this variability is almost never taken into account. EEG-Feedback aims to resolve these issues by evaluating the consequences of individual variability in cingulate cortex morphology on 1) surface EEG markers of feedback monitoring and 2) functional connectivity patterns thanks to resting-state fMRI.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

31

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Bron, Francia, 69677
        • Hospices Civils de Lyon, Groupement Hospitalier Est

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • being able to provide a writen consent form
  • having a social insurance
  • have a normal vision (with or without corrections)
  • Right-handed

Exclusion Criteria:

  • Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc…).
  • Subjects must be willing to be advise in case of discovery of brain abnormality.
  • No history of known neurological or psychiatric illness
  • Pregnant or nursing women
  • Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty, as well as legal persons protected by law

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Each subject will conduct 3 sessions, i.e. a training session, an anatomical MRI session and an EEG session. The first session will be to train the subject to carry out the different behavioral tasks that he will then have to perform during the session of EEG.
Each subject will be trained to perform a trial-error learning task. In this task, three visual stimuli will be presented to the subject. The subject will have to find by trial-error, the one associated with positive feedback, the other stimuli being associated with negative feedback (search period). Once the stimulus is associated with positive feedback, the subject will perform a period of repetition during which he will choose the stimulus associated with positive feedback. Two variants of the task will be used: a variant in which feedback will be visual (ie positive feedback = green square, negative feedback = red square) and a variant in which feedback will be fruit juice (ie positive feedback = Fruit juice (but less than 2ml), negative feedback = no volume or small volume of fruit juice).
Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained. For each task, the time of presentation of the stimuli will be 2s. During this time, the subject should indicate his choice of stimulus. After a delay of 2s, feedback will be presented for 1s. Each test shall be separated by an inter-test delay of 3s. The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained and then an EEG session during which he will perform the task learned.For each task, the time of presentation of the stimuli will be 2s. During this time, the subject should indicate his choice of stimulus. After a delay of 2s, feedback will be presented for 1s. Each test shall be separated by an inter-test delay of 3s. The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Resting state fMRI data
Periodo de tiempo: 3 years
BOLD signal will be analyzed in the low frequency band (0.1-0.01Hz). Images must be not too much distorted to allow data analysis. As such, if a subject moved too much (translation>10mm; rotation>5°) the corresponding data will be excluded from the analysis.
3 years
EEG data
Periodo de tiempo: 3 years
If recordings are too noisy (if only <30% of trials survive the denoising process), subject will be excluded from final analysis.
3 years
Behavioral data in the EEG experiment
Periodo de tiempo: 3 years
Performance in the task will be assessed. If performance in the task is <80%, subjects will be excluded in the final analysis.
3 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Christian SCHEIBER, MD, Hospices Civils de Lyon

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de enero de 2013

Finalización primaria (Actual)

6 de septiembre de 2013

Finalización del estudio (Actual)

4 de julio de 2017

Fechas de registro del estudio

Enviado por primera vez

9 de marzo de 2017

Primero enviado que cumplió con los criterios de control de calidad

13 de abril de 2017

Publicado por primera vez (Actual)

19 de abril de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 69HCL16_0659

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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