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- Ensaio Clínico NCT07635615
Brain Oscillations and Neural States (PHAROS)
Relationship Between Brain Oscillations and Neural States
The study aims to investigate, through the use of electroencephalography (EEG), instantaneous brain states, namely rapid oscillations of the brain's electrical activity, and their relationship with behavior and brain functions. The study will focus on three main objectives: (1) establishing a relationship between brain oscillations and behavior; (2) establishing a relationship between brain oscillations and brain functions, in terms of neural responsiveness; and (3) identifying the different phases of brain oscillations and investigating any related modulations of behavior and brain functions.
PHAROS will combine EEG with transcranial magnetic stimulation (TMS) to investigate and modulate brain states non-invasively.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Venice-Lido, Itália
- IRCCS San Camillo Hospital, Venice, Italy
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- Left-handedness (assessed through the Oldfield test)
- Diagnosis of neurological or psychiatric disorders
- Vision problems that prevent reading, not correctable with lenses
- Diagnosis of substance dependence on drugs or alcohol
- Presence of hearing aids/prostheses
- Diagnosis of epilepsy or family history up to the second degree with it
- Episodes of febrile convulsions or recurrent fainting
- Head trauma
- Presence of surgical clips or metal implants in the head
- Diagnosis of heart disease
- Presence of a cardiac pacemaker or artificial heart valve
- Presence of hearing aids/prostheses
- Hearing problems or tinnitus
- Vision problems not corrected with lenses (such as color blindness)
- Taking tricyclic antidepressant medications
- Taking neuroleptic medications
- Diagnosis of headache or migraine
- Taking more than 3 alcoholic units in the last 24 hours
- Taking 2 or more cups of coffee or caffeine from other sources in the last 2 hours
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Real motion
Participants will be asked to perform a possible motor imagery task: imagining an abduction movement of the right index finger.
Each session will consist of three blocks, counterbalanced across participants.
During these blocks, single TMS pulses will be delivered at different phases of the EEG oscillation: positive peak, negative peak, and random phase, the latter serving as the control condition.
|
Imagining an abduction movement of the right index finger
Imagining the right index finger remaining still, which will serve as the control condition
|
|
Comparador Falso: No motion
Participants will be asked to perform a possible motor imagery task: imagining the right index finger remaining still, which will serve as the control condition.
Each session will consist of three blocks, counterbalanced across participants.
During these blocks, single TMS pulses will be delivered at different phases of the EEG oscillation: positive peak, negative peak, and random phase, the latter serving as the control condition.
|
Imagining an abduction movement of the right index finger
Imagining the right index finger remaining still, which will serve as the control condition
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Motor-evoked potential
Prazo: Baseline
|
Motor-evoked potentials (MEPs) will be recorded from the right index-finger abductor muscle following single-pulse TMS delivered over the primary motor cortex.
MEPs will be used as an index of corticospinal excitability.
The main outcome measure will be the peak-to-peak MEP amplitude, calculated as the difference between the maximum and minimum EMG signal within the post-stimulation time window.
|
Baseline
|
|
Motor-evoked potential
Prazo: Immediately after the intervention
|
Motor-evoked potentials (MEPs) will be recorded from the right index-finger abductor muscle following single-pulse TMS delivered over the primary motor cortex.
MEPs will be used as an index of corticospinal excitability.
The main outcome measure will be the peak-to-peak MEP amplitude, calculated as the difference between the maximum and minimum EMG signal within the post-stimulation time window.
|
Immediately after the intervention
|
|
TMS-evoked potential
Prazo: Baseline
|
TMS-evoked potentials (TEPs) will be recorded using EEG following single-pulse TMS.
TEPs will be used as an index of cortical responsiveness to stimulation.
The main outcome measures will be the amplitude and latency of the main TEP components within predefined post-stimulation time windows.
|
Baseline
|
|
TMS-evoked potential
Prazo: Immediately after the intervention
|
TMS-evoked potentials (TEPs) will be recorded using EEG following single-pulse TMS.
TEPs will be used as an index of cortical responsiveness to stimulation.
The main outcome measures will be the amplitude and latency of the main TEP components within predefined post-stimulation time windows.
|
Immediately after the intervention
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2024.01
Plano para dados de participantes individuais (IPD)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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