NCT03286387

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 11, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2019

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

September 14, 2017

Last Update Submit

August 26, 2025

Conditions

Keywords

MemorynaturalisticcontextfMRIAttention

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    up to 1 week after the end of the encoding session

Study Arms (1)

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)

Other: Functional brain imaging without any contrast agent

Interventions

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).

Memory for naturalistic episodes

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U1028 INSERM - CNRS UMR 5292 Equipe ImpAct

Bron, 69500, France

Location

Related Publications (2)

  • 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.

    PMID: 38575698BACKGROUND
  • 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.

    PMID: 34272405BACKGROUND

MeSH Terms

Interventions

Functional Neuroimaging

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Emiliano MACALUSO, PhD

    INSERM U1028 - Impact - CRNL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

October 11, 2018

Primary Completion

August 13, 2019

Study Completion

August 13, 2019

Last Updated

September 3, 2025

Record last verified: 2025-08

Locations