Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.
18 de abril de 2016 atualizado 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.
Visão geral do estudo
Status
Rescindido
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
158
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 40 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Outputs of the memory task
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
CANTAB task
Prazo: Day 1 and Day 15
|
|
Day 1 and Day 15
|
|
Gene expression
Prazo: Day 1
|
Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.
|
Day 1
|
|
Imaging
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Christine Audebert, Cic-Cpcet
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2013
Conclusão Primária (Real)
1 de dezembro de 2015
Conclusão do estudo (Real)
1 de dezembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
16 de maio de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2013
Primeira postagem (Estimativa)
23 de maio de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
19 de abril de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de abril de 2016
Última verificação
1 de abril de 2016
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- WP1P003
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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