- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Venice-Lido, Italien
- IRCCS San Camillo Hospital, Venice, Italy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Sham-komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor-evoked potential
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024.01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .