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OpenTrials
Completed

NCT Number: NCT03286387

Contextual Associations During Episodic Recall of Everyday or Virtual Reality

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U1028 INSERM - CNRS UMR 5292 Equipe ImpAct

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional brain imaging without any contrast agent

Other

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: BREAL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2017
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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