Investigating the Plasticity of Human Predictive Coding Through Neuromodulation (PREDICOM)

Università Vita-Salute San Raffaele

Status: Enrolling

Conditions: Human Brain and Cognition

Treatments: Procedure: Occipital tACS at IAF+2Hz; Procedure: Sham/placebo tRNS; Procedure: Occipital tACS at IAF-2Hz; Procedure: Frontal tRNS; Procedure: Occipital tRNS; Procedure: Frontal tACS at 4-7 Hz; Procedure: Sham/placebo tACS

Study type: Interventional

Funder types: Other

Identifiers

NCT06374433

PREDICOM-01

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 7 patient groups

Occipital tACS at IAF-2Hz

Experimental group

Description:

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).

Treatment:

Procedure: Occipital tACS at IAF-2Hz

Occipital tACS at IAF+2Hz

Experimental group

Description:

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).

Treatment:

Procedure: Occipital tACS at IAF+2Hz

Frontal tACS at 4-7 Hz

Experimental group

Description:

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).

Treatment:

Procedure: Frontal tACS at 4-7 Hz

Sham/placebo tACS

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham/placebo tACS

Occipital tRNS

Experimental group

Description:

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

Treatment:

Procedure: Occipital tRNS

Frontal tRNS

Experimental group

Description:

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

Treatment:

Procedure: Frontal tRNS

Sham/placebo tRNS

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham/placebo tRNS