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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Venice-Lido, Italia
- IRCCS San Camillo Hospital, Venice, Italy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Motor-evoked potential
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Immediately after the intervention
|
|
TMS-evoked potential
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024.01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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