HealthyNCT04643340
Imaging During Subliminal Perception
An observational study of Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Subliminal perception of visual stimuli can be studied with functional brain imaging, e.g. with functional magnetic resonance imaging (fMRI). However, it is unclear how subliminal perception affects connectivity in the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- real-time fMRI
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Healthy adults (> 18 < 80 years), which can read and sign the informed consent form
- Male and female
- Right-handed
Who cannot join
- metallic items in the body (i.e. eye splinter, MR incompatible implants)
- pacemaker
- claustrophobia
- pregnant participants
- participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease and with major psychiatric disorders such as schizophrenia, depression, or anxiety disorder
- Drug intake (psychopharmaca)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Imaging During Subliminal Perception
Subliminal perception of visual stimuli can be studied with functional brain imaging, e.g. with functional magnetic resonance imaging (fMRI). However, it is unclear how subliminal perception affects connectivity in the brain.
Further, it is not known if real-time (rt) fMRI neurofeedback of brain areas involved in subliminal perception can lead to supra-threshold perception.
For attention tasks, the investigators hypothesize that functional connectivity strength is mediated by the insular cortex during both supra-threshold and subliminal perception.
Additionally, the investigators hypothesize that rt-fMRI neurofeedback training should alter neuronal and behavioral responses.
Read the detailed description
In this project, using healthy adults, the investigators have 2 aims:
- Apply electroencephalography (EEG) and fMRI before and after rt-fMRI neurofeedback during attention tasks to identify brain regions involved in subliminal and supraliminal perception.
- Apply functional connectivity analyses during these tasks.
- Conditions
- Healthy
- Being tested
- real-time fMRI
- Keywords
- functional MRI, subliminal perception, EEG, neurofeedback, attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRIOther
Brain regions can be trained, i.e. fMRI activity can be actively modulated online by humans, using rt-fMRI (Bruhl, Scherpiet et al. 2014, Bruhl 2015, Emmert, Kopel et al. 2016).
| Study group | Role | What they receive |
|---|---|---|
| active group 1 | This group will train the insular cortex by real-time fMRI Receives: Other: real-time fMRI | |
| active group 2 | This group will train the visual cortex by real-time fMRI Receives: Other: real-time fMRI | |
| sham | This group will only train the insula by a particular strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI during supra-threshold and subliminal perception
Measured: 2020 - 2022
rt-fMRI activity
rt-fMRI activity: fMRI signal changes during repetitive real time fMRI based training
Measured: 2020 - 2022
Secondary outcomes (3)
Functional connectivity
Examination of fMRI signal dependencies (coherence) between brain regions.
Measured: 2020 - 2022
EEG activity
EEG activity: Event related potentials and spectral band power for different trial types
Measured: 2020 - 2022
fMRI task performance
Reaction time and accuracy
Measured: 2020 - 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start15 Mar 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Lars Michels, PhD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643340
- Sponsor's protocol ID
- 2017-00483
- Other IDs
- 2017
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2020
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw imaging data can be shared with other groups (outside of the USZ), e.g. for replication purpose.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imaging During Subliminal Perception
- ClinicalTrials.gov ID
- NCT04643340
- Acronym / sponsor ID
- 2017-00483
- Conditions
- Healthy
- Keywords
- functional MRI, subliminal perception, EEG, neurofeedback, attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 25 Nov 2020 (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.
Subliminal perception of visual stimuli can be studied with functional brain imaging, e.g. with functional magnetic resonance imaging (fMRI). However, it is unclear how subliminal perception affects connectivity in the brain.
Further, it is not known if real-time (rt) fMRI neurofeedback of brain areas involved in subliminal perception can lead to supra-threshold perception.
For attention tasks, the investigators hypothesize that functional connectivity strength is mediated by the insular cortex during both supra-threshold and subliminal perception.
Additionally, the investigators hypothesize that rt-fMRI neurofeedback training should alter neuronal and behavioral responses.
Detailed description
In this project, using healthy adults, the investigators have 2 aims:
- Apply electroencephalography (EEG) and fMRI before and after rt-fMRI neurofeedback during attention tasks to identify brain regions involved in subliminal and supraliminal perception.
- Apply functional connectivity analyses during these tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active group 1 | – | Other: real-time fMRIThis group will train the insular cortex by real-time fMRI |
| active group 2 | – | Other: real-time fMRIThis group will train the visual cortex by real-time fMRI |
| sham | – | –This group will only train the insula by a particular strategy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (3 listed)
- Healthy adults (> 18 < 80 years), which can read and sign the informed consent form
- Male and female
- Right-handed
Key exclusion criteria (6 listed)
- metallic items in the body (i.e. eye splinter, MR incompatible implants)
- pacemaker
- claustrophobia
- pregnant participants
- participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease and with major psychiatric disorders such as schizophrenia, depression, or anxiety disorder
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 |
|---|---|---|
| real-time fMRIBrain regions can be trained, i.e. fMRI activity can be actively modulated online by humans, using rt-fMRI (Bruhl, Scherpiet et al. 2014, Bruhl 2015, Emmert, Kopel et al. 2016). | Other | active group 1, active group 2 |
Primary outcome
fMRI during supra-threshold and subliminal perception
Time frame: 2020 - 2022
rt-fMRI activity
Time frame: 2020 - 2022
rt-fMRI activity: fMRI signal changes during repetitive real time fMRI based training
3 secondary outcomes
Functional connectivity
Time frame: 2020 - 2022
EEG activity
Time frame: 2020 - 2022
fMRI task performance
Time frame: 2020 - 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: Undecided. Raw imaging data can be shared with other groups (outside of the USZ), e.g. for replication purpose.
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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. This study is not recruiting at the moment.
Lars Michels, PhD principal investigator
University Hospital, Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Zurich at 1 site in Switzerland.
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 6 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: finished, as of the sponsor's last update on 13 Jun 2023. 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 Switzerland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI during supra-threshold and subliminal perception (time frame: 2020 - 2022). The study lists 2 primary outcomes in all. 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 13 Jun 2023.