Università Vita-Salute San Raffaele
Milan, 20132, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT06374433
Investigating the Plasticity of Human Predictive Coding Through Neuromodulation
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.
Recruiting
Interested in participating?
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Conditions
Age range
18 year–35 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Occipital tACS at IAF-2Hz
ProceduretACS applied to occipital areas at 2 Hz below the individual alpha frequency (IAF)
Occipital tACS at IAF+2Hz
ProceduretACS applied to occipital areas at 2 Hz above the individual alpha frequency (IAF)
Frontal tACS at 4-7 Hz
ProceduretACS applied to frontal areas at 4-7 Hz
Occipital tRNS
ProceduretRNS applied to occipital brain regions
Frontal tRNS
ProceduretRNS applied to frontal brain regions
Sham/placebo tACS
ProceduretACS is activated only for 30 seconds and then turned off, thus resulting ineffective
Sham/placebo tRNS
ProceduretRNS is activated only for 30 seconds and then turned off, thus resulting ineffective
Primary outcomes
-
Behavioral measures
Time frame: 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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Università Vita-Salute San Raffaele
Other
Collaborators
- Alessia Santoni
- Giuseppe Di Dona
- Klara Hemmerich
- Luigi Ferini-Strambi
- Sara Stottmeier
Registry information
Official study title
Investigating the Plasticity of Human Predictive Coding Through Neuromodulation: an Interventional, Monocentric, Randomized, Single-blinded Study on Healthy Adult Volunteers
Acronym: PREDICOM
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 18, 2024
- Registry last updated
- Jun 14, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.