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Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.

18 de abril de 2016 actualizado por: Qualissima

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart

Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).

Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.

The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

158

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

      • Barcelona, España, 08036
        • IDIBAPS
      • Marseille, Francia, 13005
        • Cic-Cpcet

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

No

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  • Healthy male subjects aged between 18 and 40 years-old inclusive.
  • Education level: at least secondary.
  • Right-handed (Edinburgh Handedness Inventory).
  • The subjects are in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs.
  • No history of psychiatric disorders (assessed by Structured Clinical Interview for DSM IV Disorders (SCID) for Barcelona and by the Mini International Neuropsychiatric Interview (MINI) for Marseille).
  • No history of neurological disorders
  • No history of concussion (cranial or facial trauma) without or with loss of consciousness.
  • Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor...).
  • Subject without lesion on MRI.
  • Subject without abnormal electrical activities on standard clinical EEG.
  • No history of drug or alcohol abuse.
  • No smoker or ≤ 5 cg/ day.
  • The subject can complete the neuropsychological test battery during the training session.
  • Subject without contraindication to MRI.
  • The subject is able to read and understand the Information Form and comply with the protocol instructions and restrictions.
  • The subject is covered by a social insurance.
  • The subject has provided written informed consent.

Exclusion Criteria:

  • History or presence of psychiatric illness (Psychiatric interview).
  • History or presence of neurologic illness.
  • The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
  • The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
  • Presence of metallic objects within the body.
  • Subjects with pacemaker.
  • Claustrophobia.
  • Individual and familial history of epileptic seizure.
  • Any medication listed (see annexe) in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.
  • Subject with a correct hit rate during the retrieval session of the memory task

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

  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ineffective rTMS - Active TBS - fMRI
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
Experimental: Effective rTMS - Active TBS - fMRI
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
Comparador falso: ineffective rTMS - Sham TBS - fMRI
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
Comparador falso: Effective rTMS - Sham TBS - fMRI
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
Experimental: ineffective rTMS - Active TBS - EEG
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
Experimental: Effective rTMS - Active TBS - EEG
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
Comparador falso: ineffective rTMS - Sham TBS - EEG
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
Comparador falso: Effective rTMS - Sham TBS - EEG
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Outputs of the memory task
Periodo de tiempo: up to Day 15
outputs: number of correct answers during the retrieval event-related task (Hit rate) and the rate of false recognition of novel pictures (False Alarms rate).
up to Day 15

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
CANTAB task
Periodo de tiempo: Day 1 and Day 15
  • CANTAB / Rapid Visual Information Processing (RVIP)
  • CANTAB / Spatial Working Memory (SWM)
  • CANTAB / Paired Associates Learning (PAL)
Day 1 and Day 15
Gene expression
Periodo de tiempo: Day 1
Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.
Day 1
Imaging
Periodo de tiempo: Day1 and Day 15

Functional MRI (Barcelona): modifications will be highlighted by changes in Blood Oxydation level Dependence (BOLD)signal patterns

EEG (Marseille): modifications will be highlighted by changes in EEG markers

Day1 and Day 15

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Christine Audebert, Cic-Cpcet

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

1 de mayo de 2013

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

16 de mayo de 2013

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2013

Publicado por primera vez (Estimar)

23 de mayo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de abril de 2016

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

18 de abril de 2016

Última verificación

1 de abril de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • WP1P003

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

producto fabricado y exportado desde los 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 ineffective rTMS

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