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

Investigating the Plasticity of Human Predictive Coding Through Neuromodulation: an Interventional, Monocentric, Randomized, Single-blinded Study on Healthy Adult Volunteers

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Ronconi, PhD; Phone Number: 0226434887; Email: ronconi.luca@unisr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • Università Vita-Salute San Raffaele
    • Contact: Luca Ronconi; Phone Number: 0226434887; Email: ronconi.luca@unisr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: Occipital tACS at IAF-2Hz; tACS applied to occipital areas at 2 Hz below the individual alpha frequency (IAF)
Experimental: 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).	Procedure: Occipital tACS at IAF+2Hz; tACS applied to occipital areas at 2 Hz above the individual alpha frequency (IAF)
Experimental: 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).	Procedure: Frontal tACS at 4-7 Hz; tACS applied to frontal areas at 4-7 Hz
Sham Comparator: 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.	Procedure: Sham/placebo tACS; tACS is activated only for 30 seconds and then turned off, thus resulting ineffective
Experimental: Occipital tRNS; Stimulation at occipital sites with transcranial random noise stimulation (tRNS) to modulate occipital brain areas plasticity	Procedure: Occipital tRNS; tRNS applied to occipital brain regions
Experimental: Frontal tRNS; Stimulation at frontal sites with transcranial random noise stimulation (tRNS) to modulate frontal brain areas plasticity	Procedure: Frontal tRNS; tRNS applied to frontal brain regions
Sham Comparator: 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.	Procedure: Sham/placebo tRNS; tRNS is activated only for 30 seconds and then turned off, thus resulting ineffective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral measures	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).	During the procedure

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele
• Collaborators: Alessia Santoni; Sara Stottmeier; Klara Hemmerich; Giuseppe Di Dona; Luigi Ferini-Strambi

Study record dates

Study Major Dates

• Study Start (Estimated): June 13, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PREDICOM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No