Healthy VolunteersBREALNCT03286387
Contextual Associations During Episodic Recall of Everyday or Virtual Reality
A study testing Functional brain imaging without any contrast agent in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The project is dedicated to development of new paradigms to investigate memory and attention in the rich and realistic environments. The investigator will use modern interactive digital technologies for encoding complex episodes either using mobile phone technology in everyday life or using a virtual reality life-like… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Functional brain imaging without any contrast agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2018to 13 Aug 2019
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Possession a Smartphone compatible with GPS 3-rd generation and exploitation system Android 4.2 with user-activated geolocation (for mobile phone studies).
- Able to navigate in virtual reality with a help of the keyboard (for virtual reality studies).
- Not using glasses.
- All subjects will give their written consent for participation in the study.
- They will be right-handed
- They will have French social coverage.
Who cannot join
- Previous neurologic or psychiatric disease.
- Cognitive deficits restricting understanding of the tasks.
- Pregnant or breath-feeding women.
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty.
- Subjects currently participating in other study.
- Additional exclusion criteria for an fMRI recording
Show all 15Show fewer
- Neurologic, cardiac electrostimulation or defibrillator.
- Cardiac prostheses
- Intracranial clips or clamps
- Cerebrospinal fluid disorders
- Metal particles in the eyes
- Metal dental or articular prostheses
- Diffusion pomp or other infusion system
- Claustrophobia
- Head tattoo , makeup, hair gel
Trial locations and contacts
1 site in 1 country.
About this study
The project is dedicated to development of new paradigms to investigate memory and attention in the rich and realistic environments. The investigator will use modern interactive digital technologies for encoding complex episodes either using mobile phone technology in everyday life or using a virtual reality life-like simulation.
He aims to characterize the role of the medial temporal lobe and prefrontal cortex during recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy participants. The secondary aim is assess how the allocation of attention during memory encoding contribute to mechanisms of the subsequent recall. He will achieve this by monitoring gaze direction during encoding and by analyzing the retrieval data as a function of the elements that participants attended / fixated during encoding.
The protocol will involve, first, behavioral testing of memory performance with encoding in the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI will be used to measure brain activity during retrieval.
- Conditions
- Healthy Volunteers
- Being tested
- Functional brain imaging without any contrast agent
- Keywords
- Memory, naturalistic, context, fMRI, Attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional brain imaging without any contrast agentOther
During the fMRI protocol, the subject will perform the retrieval tasks while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (TE) = 30 ms, Repetition Time (TR) = 2.5 sec). The functional session will be subdivided into several parts ("Runs", duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min).
| Study group | Role | What they receive |
|---|---|---|
| Memory for naturalistic episodes | Experimental | Encoding of episode in real life situations (using Smartphones) or in a virtual environment, followed by memory retrieval (either behavior only or with fMRI, in successive studies) Receives: Other: Functional brain imaging without any contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD cerebral response to contextual recall in medial temporal lobe
After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for SPM analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p<0.05 FWE within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.
Measured: up to 1 week after the end of the encoding session
BOLD cerebral response to contextual recall in prefrontal cortex
After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for Statistical Parametric Mapping (SPM) analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p<0.05 Family-wise error (FWE) within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.
Measured: up to 1 week after the end of the encoding session
Secondary outcomes (1)
Pattern of gaze fixation during episodic encoding and cerebral activity during recall
The gaze direction during both during episodic encoding and recall. We will estimate a correlation between the activation of medial temporal lobe/ prefrontal cortex and the similarity of the gaze fixations during encoding and retrieval. A positive correlation will support our hypothesis about the link between attention and contextual encoding.
Measured: up to 1 week after the end of the encoding session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start11 Oct 2018
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emiliano MACALUSO, PhD, Principal investigator, INSERM U1028 - Impact - CRNL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286387
- Sponsor's protocol ID
- 69HCL17_0404
- Other IDs
- 2017-A02558-45
- Acronym
- BREAL
- Status last verified
- Aug 2025
- First submitted
- 14 Sep 2017
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Foudil SA, Macaluso E. The influence of the precuneus on the medial temporal cortex determines the subjective quality of memory during the retrieval of naturalistic episodes. Sci Rep. 2024 Apr 4;14(1):7943. doi: 10.1038/s41598-024-58298-y.
PubMed 38575698Foudil SA, Pleche C, Macaluso E. Memory for spatio-temporal contextual details during the retrieval of naturalistic episodes. Sci Rep. 2021 Jul 16;11(1):14577. doi: 10.1038/s41598-021-93960-9.
PubMed 34272405
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contextual Associations During Episodic Recall of Everyday or Virtual Reality
- ClinicalTrials.gov ID
- NCT03286387
- Acronym / sponsor ID
- BREAL / 69HCL17_0404
- Conditions
- Healthy Volunteers
- Keywords
- Memory, naturalistic, context, fMRI, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 18 Sep 2017 (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 project is dedicated to development of new paradigms to investigate memory and attention in the rich and realistic environments. The investigator will use modern interactive digital technologies for encoding complex episodes either using mobile phone technology in everyday life or using a virtual reality life-like simulation.
He aims to characterize the role of the medial temporal lobe and prefrontal cortex during recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy participants. The secondary aim is assess how the allocation of attention during memory encoding contribute to mechanisms of the subsequent recall. He will achieve this by monitoring gaze direction during encoding and by analyzing the retrieval data as a function of the elements that participants attended / fixated during encoding.
The protocol will involve, first, behavioral testing of memory performance with encoding in the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI will be used to measure brain activity during retrieval.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory for naturalistic episodes | Experimental | Other: Functional brain imaging without any contrast agentEncoding of episode in real life situations (using Smartphones) or in a virtual environment, followed by memory retrieval (either behavior only or with fMRI, in successive studies) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Possession a Smartphone compatible with GPS 3-rd generation and exploitation system Android 4.2 with user-activated geolocation (for mobile phone studies).
- Able to navigate in virtual reality with a help of the keyboard (for virtual reality studies).
- Not using glasses.
- All subjects will give their written consent for participation in the study.
- They will be right-handed
Key exclusion criteria (15 listed)
- Previous neurologic or psychiatric disease.
- Cognitive deficits restricting understanding of the tasks.
- Pregnant or breath-feeding women.
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty.
- Subjects currently participating in other study.
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 |
|---|---|---|
| Functional brain imaging without any contrast agentDuring the fMRI protocol, the subject will perform the retrieval tasks while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (TE) = 30 ms, Repetition Time (TR) = 2.5 sec). The functional session will be subdivided into several parts ("Runs", duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min). | Other | Memory for naturalistic episodes |
Primary outcome
BOLD cerebral response to contextual recall in medial temporal lobe
Time frame: up to 1 week after the end of the encoding session
After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for SPM analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p<0.05 FWE within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.
BOLD cerebral response to contextual recall in prefrontal cortex
Time frame: up to 1 week after the end of the encoding session
After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for Statistical Parametric Mapping (SPM) analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p<0.05 Family-wise error (FWE) within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.
1 secondary outcome
Pattern of gaze fixation during episodic encoding and cerebral activity during recall
Time frame: up to 1 week after the end of the encoding session
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 3 Sep 2025.
- Results publication: PubMed 38575698Foudil SA, Macaluso E. The influence of the precuneus on the medial temporal cortex determines the subjective quality of memory during the retrieval of naturalistic episodes. Sci Rep. 2024 Apr 4;14(1):7943. doi: 10.1038/s41598-024-58298-y.
- Results publication: PubMed 34272405Foudil SA, Pleche C, Macaluso E. Memory for spatio-temporal contextual details during the retrieval of naturalistic episodes. Sci Rep. 2021 Jul 16;11(1):14577. doi: 10.1038/s41598-021-93960-9.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
Emiliano MACALUSO, PhD principal investigator
INSERM U1028 - Impact - CRNL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional brain imaging without any contrast agent in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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 6 inclusion and 15 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 3 Sep 2025. 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 France. 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?
BOLD cerebral response to contextual recall in medial temporal lobe (time frame: up to 1 week after the end of the encoding session). 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?
On the ClinicalTrials.gov record for NCT03286387, which also lists 2 linked publications.
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 3 Sep 2025.