Investigating the Plasticity of Human Predictive Coding Through Neuromodulation

Not Applicable

Recruiting

• Conditions: Human Brain and Cognition
• Interventions: Procedure: Frontal tRNS; Procedure: Occipital tACS at IAF-2Hz; Procedure: Frontal tACS at 4-7 Hz; Procedure: Sham/placebo tACS; Procedure: Occipital tACS at IAF+2Hz; Procedure: Occipital tRNS; Procedure: Sham/placebo tRNS

• Registration Number: NCT06374433
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Status Verified: 2024-06
• Study Start: 2024-06-13
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frontal tRNS	Frontal tRNS	Stimulation at frontal sites with transcranial random noise stimulation (tRNS) to modulate frontal brain areas plasticity
Occipital tACS at IAF-2Hz	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).
Frontal tACS at 4-7 Hz	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).
Sham/placebo tACS	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.
Occipital tACS at IAF+2Hz	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).
Occipital tRNS	Occipital tRNS	Stimulation at occipital sites with transcranial random noise stimulation (tRNS) to modulate occipital brain areas plasticity
Sham/placebo tRNS	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.

Primary Outcome Measures

Name	Time	Method
Behavioral measures	During the procedure	To study if tACS or tRNS delivered in different brain networks can modulate the learning of statistical regularities in the context of visual perception we will evaluate the following behavioral measures recorded in a computerized visual perception task: hit rate, miss, false alarms, correct rejections. These behavioral measures will allow to derive measures of sensitivity (d') and response criterion (Beta and C), according to the theoretical framework of the Signal Detection Theory (SDT).

Trial Locations

Locations (1)

Università Vita-Salute San Raffaele; 🇮🇹 Milan, Italy