NCT05308433

Brief Summary

The aim of this study is to, using fMRI, compare brain activations during olfactory imagery induced by different visual supports (words, pictures, colors and colored arrangements) in healthy subjects. This will allow us to choose the best olfactory imagery facilitator and to assess its effect on cybersickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2022

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

March 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

March 4, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

fMRI

Outcome Measures

Primary Outcomes (1)

  • Comparison of cerebral activations between the different supports mediating the olfactory imagination during the execution of the fMRI tasks.

    The cerebral activations between the different supports mediating the olfactory imagination will be compared in terms of localization and intensity of the variations of the BOLD signal during the execution of the fMRI tasks.

    Baseline (J0)

Secondary Outcomes (6)

  • Determination of the visual support allowing the strongest olfactory imagination during the fMRI by subjective evaluations using two 4-level Likert scales.

    Baseline (J0)

  • Determination of the visual support allowing the strongest olfactory imagination during the fMRI test by the cerebral activations in areas recognized for their implications in the olfactory imagination.

    Baseline (J0)

  • Description of the evolution of the cardiac activity during olfactory imagination tasks in fMRI.

    Baseline (J0)

  • Description of the evolution of the respiratory activity during olfactory imagination tasks in fMRI.

    Baseline (J0)

  • Evaluation of the state of discomfort in virtual reality by measuring the cardiac activity.

    Baseline (J0) and 6 months maximum after J0 (V1)

  • +1 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL
Device: Functional MRIOther: Virtual Reality: controlOther: Virtual Reality: experimental

Interventions

The volunteer will have to imagine the smells evoked by different visual aids. This task will be carried out during 2 acquisition runs of about 10 minutes each. The volunteer should note (on a scale from 1 to 4) the pleasantness of the smell evoked.

Also known as: fMRI
Experimental

The volunteer will be immersed in a virtual maritime environment with nauseating characteristics. In the center of the maritime scene, it will be visible the black outlines of a frame. Every minute, the volunteer will be asked to verbalize the level of his general condition via the Fast Motion Sickness Scale (1 to 20).

Also known as: VR control
Experimental

The volunteer will be immersed in a virtual maritime environment with nauseating characteristics. The visual support inserted in the center of the virtual scene will be the one defined as being the most facilitator of the olfactory imagination during the fMRI examination. The volunteer will be asked to concentrate on the smell evoked by this support. Every minute, the volunteer will be asked to verbalize the level of his general condition via the Fast Motion Sickness Scale (1 to 20).

Also known as: VR experimental
Experimental

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to be of French nationality who has always lived in metropolitan France;
  • to be right-handed person;
  • to be enrolled in a social security plan;
  • to be able to understand the instructions given;
  • to give a written consent;
  • Person with a strong capacity for olfactory imagination: having obtained a score strictly below 2.5 on the fVOIQ olfactory imagination questionnaire.

You may not qualify if:

  • to have an inability to read French;
  • to be recognized as a synesthete;
  • to have a professional activity requires intense olfactory activity;
  • to have a partial or total loss of smell (hyposmia, anosmia);
  • to have qualitative smell disorders (carcosomia, hyperosmia, phantosmia, parosmia);
  • to have smell disorders of neurological, post-traumatic or neurodegenerative origin;
  • to have uncorrected or poorly corrected visual disturbances;
  • to have vestibular disorder diagnosed;
  • any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … );
  • subject under a measure of legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

Location

Related Publications (1)

  • Fantin L, Ceyte H, Ramdane-Cherif Z, Jacquot M, Hossu G. French Vividness of Olfactory Imagery Questionnaire: A Potential Tool for Diagnosing Olfactory Loss by Assessing Olfactory Imagery? Front Psychol. 2020 Dec 21;11:606667. doi: 10.3389/fpsyg.2020.606667. eCollection 2020.

    PMID: 33408672BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 4, 2022

Study Start

April 13, 2022

Primary Completion

July 12, 2022

Study Completion

October 26, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations