BREAL: Contextual Associations During Episodic Recall of Everyday or Virtual Reality

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03286387
Collaborator
(none)
450
1
1
61
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Functional brain imaging without any contrast agent
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Contextual Associations During Episodic Recall of Everyday or Virtual Reality
Actual Study Start Date :
Oct 11, 2018
Anticipated Primary Completion Date :
Nov 11, 2023
Anticipated Study Completion Date :
Nov 11, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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).

Outcome Measures

Primary Outcome Measures

  1. BOLD cerebral response to contextual recall in medial temporal lobe [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.

  2. BOLD cerebral response to contextual recall in prefrontal cortex [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.

Secondary Outcome Measures

  1. Pattern of gaze fixation during episodic encoding and cerebral activity during recall [up to 1 week after the end of the encoding session]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 U1028 INSERM - CNRS UMR 5292 Equipe ImpAct Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Emiliano MACALUSO, PhD, INSERM U1028 - Impact - CRNL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03286387
Other Study ID Numbers:
  • 69HCL17_0404
  • 2017-A02558-45
First Posted:
Sep 18, 2017
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Feb 11, 2022