Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
4 de enero de 2019 actualizado por: University Hospital, Grenoble
Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
The main objective of this study is to estimate the effect of the neuromodulation on the behavioral performances during the access in semantics according to the age of the individuals.
Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by exciting or by inhibiting localized cortical zones. The modulation of the performances in cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their functional roles.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this project is to determine the changes of behavioral performances (time of answer, percentage of correct answers) further to the neuromodulation.
The specific question is to estimate the effect on the performances of access at the semantic representations of this method, according to the age.
One of the hypotheses in the research on the normal ageing is the difficulty of access to these representations (fundamental process for the cognitive functions, such as the language and the memory) at the healthy elderly.
By using the neuromodulation the investigators wish to explore this hypothesis and to understand if the neuromodulation can have a beneficial effect on the improvement of the behavioral performances of the elderly.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
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.
Estudio Contacto
- Nombre: Thierry BOUGEROL
- Número de teléfono: 04 76 76 54 11
- Correo electrónico: TBougerol@chu-grenoble.fr
Copia de seguridad de contactos de estudio
- Nombre: Laurent TORLAY
- Correo electrónico: laurent.torlay@univ-grenoble-alpes.fr
Ubicaciones de estudio
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Grenoble, Francia, 38043
- Reclutamiento
- CHU
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Contacto:
- Laurent TORLAY
- Correo electrónico: laurent.torlay@univ-grenoble-alpes.fr
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Contacto:
- Thierry BOUGEROL
- Correo electrónico: TBougerol@chu-grenoble.fr
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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 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Major healthy Subject ( 18 - 85 years)
- Right-hander
- Signed Informed consent
- A medical examination must be made before the participation for the research
- Membership in or beneficiary of a national insurance scheme
Non inclusion Criteria:
- Subject under age 18 and of more than 85 years.
- Contraindications in the practice of MRI, TMS and tES
- Existence of a severe affection on the general plan: cardiac, respiratory, hematological, renal, hepatic, cancerous
- Regular taking of anxiolytic, sedative, antidepressant, neuroleptic
- Characterized psychiatric pathology
- Ingestion of alcohol before the examination
- Pregnancy, parturiency or breast-feeding
- Private person of freedom by court or administrative order, nobody being the object of a legal protective measure (under guardianship or guardianship)
- Participation to other protocols of current search with period of exclusion or in the previous week
- Subject which would perceive more than 4500 euros of compensation because of its participation in other searches involving the human person in 12 months preceding this study.
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 18-49 years group
Participants undergo 2 sessions of MRI + transcranial Magnetic Stimulation or transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
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Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
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Experimental: 50-85 years group
Participants undergo 2 sessions of MRI + transcranial Magnetic Stimulation or transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
|
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of the neuromodulation on the behavioral performances during the access in semantics
Periodo de tiempo: 3 hours
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Evaluation of the changes of the behavioral performances before and after the neuromodulation by non-invasive cortical stimulation according to the age.
More exactly, the investigators shall compare response times before and after neuromodulation between both age groups (18-49 years and 50-85 years), by testing the interaction between the effect of the neuromodulation and the age.
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3 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estimate the effect of the neuromodulation on the behavioral performances
Periodo de tiempo: 3 hours
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Compare the percentages of correct answers before and after neuromodulation by non-invasive cortical electric stimulation, according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.
Periodo de tiempo: 3 hours
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Comparison of the neuropsychological scores before and after tES, according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of tES on the cerebral functional activity, by comparing blood-oxygen-level dependent (BOLD ) signal or functional MRI before and after tES according to the age (18-49 years vs 50-85 years).
Periodo de tiempo: 3 hours
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The investigators extract estimates parameters (Estimated Beta weight Values) corresponding to each tES stimulation.
Each session is be designed by using general linear model (Friston, 1998, statistical parametrical mapping in fMRI) defined as Ybefore tES = R1Beta1+R2Beta2 +R0Beta0 + e and Yafter tES = R1Beta1 +R2Beta2 +R0Beta0 + e, with Y = acquired BOLD signal, e = error, R1Beta1 corresponding to the task (meaning interest activation) regressor and R2Beta2 corresponding to the control (meaning no interest activation) regressor respectively convolved with the canonical hemodynamic response function (cHRf) and R0B0 corresponding to the constant regressor.
Parameter estimates are calculated by extracting Beta1 and Beta2 values for each session respectively in order to compute statistical comparison (measure by subject) on the outcome measure (Beta1 before tES - Beta1 after tES).
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3 hours
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Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.
Periodo de tiempo: 3 hours
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Comparison of the neuropsychological scores before and after Transcranial Magnetic Stimulation (TMS), according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of the TMS on the intellectual functional activity, according to the age.
Periodo de tiempo: 3 hours
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Comparison of the cerebral functional activity (electric neuronal signal, EEG) before and after TMS, according to the age (18-49 years vs 50-85 years).
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3 hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Zimerman M, Hummel FC. Non-invasive brain stimulation: enhancing motor and cognitive functions in healthy old subjects. Front Aging Neurosci. 2010 Dec 1;2:149. doi: 10.3389/fnagi.2010.00149. eCollection 2010.
- Holland R, Leff AP, Josephs O, Galea JM, Desikan M, Price CJ, Rothwell JC, Crinion J. Speech facilitation by left inferior frontal cortex stimulation. Curr Biol. 2011 Aug 23;21(16):1403-7. doi: 10.1016/j.cub.2011.07.021. Epub 2011 Aug 4.
- Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
- Liuzzi G, Freundlieb N, Ridder V, Hoppe J, Heise K, Zimerman M, Dobel C, Enriquez-Geppert S, Gerloff C, Zwitserlood P, Hummel FC. The involvement of the left motor cortex in learning of a novel action word lexicon. Curr Biol. 2010 Oct 12;20(19):1745-51. doi: 10.1016/j.cub.2010.08.034. Epub 2010 Sep 30.
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)
31 de agosto de 2017
Finalización primaria (Anticipado)
1 de junio de 2020
Finalización del estudio (Anticipado)
1 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
18 de abril de 2017
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2017
Publicado por primera vez (Actual)
30 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
4 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 38RC17.078
- 2017-A00834-49 (Otro identificador: ansm)
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. .
Ensayos clínicos sobre MRI + transcranial Magnetic Stimulation
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