- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Venice-Lido, Italia
- IRCCS San Camillo Hospital, Venice, Italy
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Comparatore fittizio: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Motor-evoked potential
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2024.01
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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