Investigating the Plasticity of Human Predictive Coding Through Neuromodulation

NCT ID: NCT06374433

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-13

Study Completion Date

2026-12-31

Brief Summary

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The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults.

Detailed Description

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Conditions

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Human Brain and Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Occipital tACS at IAF-2Hz

Transcranial alternating current stimulation (tACS) at occipital sites to modulate the occipital brain areas' activity at a frequency below the individual alpha frequency (IAF-2 Hz).

Group Type EXPERIMENTAL

Occipital tACS at IAF-2Hz

Intervention Type PROCEDURE

tACS applied to occipital areas at 2 Hz below the individual alpha frequency (IAF)

Occipital tACS at IAF+2Hz

Transcranial alternating current stimulation (tACS) at occipital sites to modulate the occipital brain areas' activity at a frequency above the individual alpha frequency (IAF+2 Hz).

Group Type EXPERIMENTAL

Occipital tACS at IAF+2Hz

Intervention Type PROCEDURE

tACS applied to occipital areas at 2 Hz above the individual alpha frequency (IAF)

Frontal tACS at 4-7 Hz

Transcranial alternating current stimulation (tACS) at frontal sites to modulate the frontal brain areas' activity at a frequency within the theta band (4-7 Hz).

Group Type EXPERIMENTAL

Frontal tACS at 4-7 Hz

Intervention Type PROCEDURE

tACS applied to frontal areas at 4-7 Hz

Sham/placebo tACS

Transcranial alternating current stimulation (tACS) is applied only in the first and the last 30 seconds of the experimental procedure, thus resulting ineffective.

Group Type SHAM_COMPARATOR

Sham/placebo tACS

Intervention Type PROCEDURE

tACS is activated only for 30 seconds and then turned off, thus resulting ineffective

Occipital tRNS

Stimulation at occipital sites with transcranial random noise stimulation (tRNS) to modulate occipital brain areas plasticity

Group Type EXPERIMENTAL

Occipital tRNS

Intervention Type PROCEDURE

tRNS applied to occipital brain regions

Frontal tRNS

Stimulation at frontal sites with transcranial random noise stimulation (tRNS) to modulate frontal brain areas plasticity

Group Type EXPERIMENTAL

Frontal tRNS

Intervention Type PROCEDURE

tRNS applied to frontal brain regions

Sham/placebo tRNS

Transcranial random noise stimulation (tRNS) is applied only in the first and the last 30 seconds of the experimental procedure, thus resulting ineffective.

Group Type SHAM_COMPARATOR

Sham/placebo tRNS

Intervention Type PROCEDURE

tRNS is activated only for 30 seconds and then turned off, thus resulting ineffective

Interventions

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Occipital tACS at IAF-2Hz

tACS applied to occipital areas at 2 Hz below the individual alpha frequency (IAF)

Intervention Type PROCEDURE

Occipital tACS at IAF+2Hz

tACS applied to occipital areas at 2 Hz above the individual alpha frequency (IAF)

Intervention Type PROCEDURE

Frontal tACS at 4-7 Hz

tACS applied to frontal areas at 4-7 Hz

Intervention Type PROCEDURE

Occipital tRNS

tRNS applied to occipital brain regions

Intervention Type PROCEDURE

Frontal tRNS

tRNS applied to frontal brain regions

Intervention Type PROCEDURE

Sham/placebo tACS

tACS is activated only for 30 seconds and then turned off, thus resulting ineffective

Intervention Type PROCEDURE

Sham/placebo tRNS

tRNS is activated only for 30 seconds and then turned off, thus resulting ineffective

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study.
* Aged 18-35 years.
* Normal or corrected to normal vision, as per anamnestic investigation.

Exclusion Criteria

* Participants with a diagnosis of epilepsy (as per anamnestic investigation).
* Participants with major neurological disorders (as per anamnestic investigation).
* Participants that are currently under psychopharmacological treatment with tricyclic antidepressants (as per anamnestic investigation).
* Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants (as per anamnestic investigation).
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alessia Santoni

UNKNOWN

Sponsor Role collaborator

Sara Stottmeier

UNKNOWN

Sponsor Role collaborator

Klara Hemmerich

UNKNOWN

Sponsor Role collaborator

Giuseppe Di Dona

UNKNOWN

Sponsor Role collaborator

Luigi Ferini-Strambi

UNKNOWN

Sponsor Role collaborator

Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Luca Ronconi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Università Vita-Salute San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Ronconi, PhD

Role: CONTACT

0226434887

Facility Contacts

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Luca Ronconi

Role: primary

0226434887

Other Identifiers

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PREDICOM-01

Identifier Type: -

Identifier Source: org_study_id

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