Human Brain and CognitionPREDICOMNCT06374433
Investigating the Plasticity of Human Predictive Coding Through Neuromodulation
A study testing Occipital tACS at IAF-2Hz, Occipital tACS at IAF+2Hz and Frontal tACS at 4-7 Hz in people with Human Brain and Cognition, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Brain and Cognition
- What is being tested?
- Occipital tACS at IAF-2Hz, Occipital tACS at IAF+2Hz and Frontal tACS at 4-7 Hz
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Vita-Salute San Raffaele
Milan, 20132
Luca Ronconi, 0226434887, ronconi.luca@unisr.it
About this study
Official title: 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.
- Conditions
- Human Brain and Cognition
- Being tested
- Occipital tACS at IAF-2Hz, Occipital tACS at IAF+2Hz, Frontal tACS at 4-7 Hz, Occipital tRNS, Frontal tRNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital tACS at IAF-2HzProcedure or surgery
tACS applied to occipital areas at 2 Hz below the individual alpha frequency (IAF)
Occipital tACS at IAF+2HzProcedure or surgery
tACS applied to occipital areas at 2 Hz above the individual alpha frequency (IAF)
Frontal tACS at 4-7 HzProcedure or surgery
tACS applied to frontal areas at 4-7 Hz
Occipital tRNSProcedure or surgery
tRNS applied to occipital brain regions
Frontal tRNSProcedure or surgery
tRNS applied to frontal brain regions
Sham/placebo tACSProcedure or surgery
tACS is activated only for 30 seconds and then turned off, thus resulting ineffective
Sham/placebo tRNSProcedure or surgery
tRNS is activated only for 30 seconds and then turned off, thus resulting ineffective
| Study group | Role | What they receive |
|---|---|---|
| Occipital tACS at IAF-2Hz | Experimental | 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). Receives: Procedure: Occipital tACS at IAF-2Hz |
| Occipital tACS at IAF+2Hz | Experimental | 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). Receives: Procedure: Occipital tACS at IAF+2Hz |
| Frontal tACS at 4-7 Hz | Experimental | 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). Receives: Procedure: Frontal tACS at 4-7 Hz |
| Sham/placebo tACS | Sham comparator | Transcranial alternating current stimulation (tACS) is applied only in the first and the last 30 seconds of the experimental procedure, thus resulting ineffective. Receives: Procedure: Sham/placebo tACS |
| Occipital tRNS | Experimental | Stimulation at occipital sites with transcranial random noise stimulation (tRNS) to modulate occipital brain areas plasticity Receives: Procedure: Occipital tRNS |
| Frontal tRNS | Experimental | Stimulation at frontal sites with transcranial random noise stimulation (tRNS) to modulate frontal brain areas plasticity Receives: Procedure: Frontal tRNS |
| Sham/placebo tRNS | Sham comparator | Transcranial random noise stimulation (tRNS) is applied only in the first and the last 30 seconds of the experimental procedure, thus resulting ineffective. Receives: Procedure: Sham/placebo tRNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start13 Jun 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Brain and CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Alessia Santoni, Sara Stottmeier, Klara Hemmerich, Giuseppe Di Dona, Luigi Ferini-Strambi
- Responsible party
- Principal investigator, Luca Ronconi, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374433
- Sponsor's protocol ID
- PREDICOM-01
- Acronym
- PREDICOM
- Status last verified
- Jun 2024
- First submitted
- 8 Apr 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Plasticity of Human Predictive Coding Through Neuromodulation: an Interventional, Monocentric, Randomized, Single-blinded Study on Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06374433
- Acronym / sponsor ID
- PREDICOM / PREDICOM-01
- Conditions
- Human Brain and Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Alessia Santoni, Sara Stottmeier, Klara Hemmerich, Giuseppe Di Dona, Luigi Ferini-Strambi
- Study start
- 13 Jun 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Occipital tACS at IAF-2Hz | Experimental | Procedure: Occipital tACS at IAF-2HzTranscranial 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). |
| Occipital tACS at IAF+2Hz | Experimental | Procedure: Occipital tACS at IAF+2HzTranscranial 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). |
| Frontal tACS at 4-7 Hz | Experimental | Procedure: Frontal tACS at 4-7 HzTranscranial 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 comparator | Procedure: Sham/placebo tACSTranscranial alternating current stimulation (tACS) is applied only in the first and the last 30 seconds of the experimental procedure, thus resulting ineffective. |
| Occipital tRNS | Experimental | Procedure: Occipital tRNSStimulation at occipital sites with transcranial random noise stimulation (tRNS) to modulate occipital brain areas plasticity |
| Frontal tRNS | Experimental | Procedure: Frontal tRNSStimulation at frontal sites with transcranial random noise stimulation (tRNS) to modulate frontal brain areas plasticity |
| Sham/placebo tRNS | Sham comparator | Procedure: Sham/placebo tRNSTranscranial random noise stimulation (tRNS) is applied only in the first and the last 30 seconds of the experimental procedure, thus resulting ineffective. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital tACS at IAF-2HztACS applied to occipital areas at 2 Hz below the individual alpha frequency (IAF) | Procedure or surgery | Occipital tACS at IAF-2Hz |
| Occipital tACS at IAF+2HztACS applied to occipital areas at 2 Hz above the individual alpha frequency (IAF) | Procedure or surgery | Occipital tACS at IAF+2Hz |
| Frontal tACS at 4-7 HztACS applied to frontal areas at 4-7 Hz | Procedure or surgery | Frontal tACS at 4-7 Hz |
| Occipital tRNStRNS applied to occipital brain regions | Procedure or surgery | Occipital tRNS |
| Frontal tRNStRNS applied to frontal brain regions | Procedure or surgery | Frontal tRNS |
| Sham/placebo tACStACS is activated only for 30 seconds and then turned off, thus resulting ineffective | Procedure or surgery | Sham/placebo tACS |
| Sham/placebo tRNStRNS is activated only for 30 seconds and then turned off, thus resulting ineffective | Procedure or surgery | Sham/placebo tRNS |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Human Brain and Cognition
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital tACS at IAF-2Hz, Occipital tACS at IAF+2Hz and Frontal tACS at 4-7 Hz in people with Human Brain and Cognition, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Ronconi, PhD (0226434887, ronconi.luca@unisr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral measures (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.