CClinicalTrials.gg
CompletedNCT03286387BREALUpdated Sep 3, 2025

Contextual Associations During Episodic Recall of Everyday or Virtual Reality

An interventional study of Functional brain imaging without any contrast agent in Healthy Volunteers, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Memory
  • naturalistic
  • context
  • fMRI
  • Attention
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Memory for naturalistic episodes

    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)

    Other: Functional brain imaging without any contrast agent

Interventions

  • OtherFunctional brain imaging without any contrast agent

    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).

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 1 week after the end of the encoding session

  2. 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.

    Time frame: 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.

    Time frame: up to 1 week after the end of the encoding session

06

Study locations

1 site
  • U1028 INSERM - CNRS UMR 5292 Equipe ImpAct
    Bron, 69500, France
07

References and documents

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 38575698 ↗
  • Foudil 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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03286387
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Oct 11, 2018
Primary completion
Aug 13, 2019
Completion
Aug 13, 2019
Last update
Sep 3, 2025

Study contacts

Emiliano MACALUSO, PhD
principal investigator · INSERM U1028 - Impact - CRNL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion