NCT03058172

Brief Summary

The aim of this research project is to better understand the reciprocal influence of visual and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the importance of olfacto-visual learning in expert situations, the degree of expertise in olfaction will also be considered. In addition, the investigators will try to better understand the differences between expert and non-expert populations in olfaction through different levels of approach: sensory, genetic and cerebral. To achieve this, the investigators will use psychophysical tests, genetic analyzes and a non-invasive technique, functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects - novices or experts in olfaction - in response to different visual and olfactory stimuli.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 15, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

5.9 years

First QC Date

February 8, 2017

Last Update Submit

July 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Brain activity

    fMRI 3T scanner in CERMEP imaging center (Bron - see web link at the end of the document), allowing anatomical measures, connectivity between olfactory and other regions (DTI), activation pattern in olfactory and visual areas.

    During the 2-hour testing session (one session per participant)

Secondary Outcomes (4)

  • Genotyping

    Sampling during the 2-hour testing session (one session per participant), analyses within 6 years after sampling

  • Olfactory abilities

    During the 2-hour testing session (one session per participant)

  • Perception

    During the 2-hour testing session (one session per participant)

  • Response times

    During the 2-hour testing session (one session per participant)

Study Arms (2)

Odors (food and non-food)

OTHER

Odorants diluted in mineral oil.

Other: Odor presentation (for participants' perception)

Pictures (food and non-food)

OTHER

Pictures of objects or scenes.

Other: Image presentation (for participants' perception)

Interventions

Several different odors will be diffused by an olfactometer under the participants' nostrils, though a controlled airflow, and synchronously with the participants' respiration. fMRI designs require repeated stimulus presentation. Odors will also be presented (in flasks or in odor pens) outside the scanner.

Odors (food and non-food)

Several different pictures will be displayed in front of the participants' face, though a through a mirror system in the scanner, or on a computer screen outside the scanner.

Pictures (food and non-food)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers
  • men and women, aged 18-85 years old
  • subjects with social security cover
  • expertise in olfaction for half of the subjects (60)

You may not qualify if:

  • subjects younger than 18 and older than 85
  • subjects with contraindications to fMRI, i.e. with pacemaker / insulin pump / metal prosthesis / intracerebral clip / neurosensory stimulator / implantable defibrillator / cochlear implants / ferromagnetic ocular or cerebral foreign body close to the nerve structures / ventriculoperitoneal neurosurgical bypass valves / braces and other non-removable metallic dental device / claustrophobic, non-cooperating or agitated subjects.
  • pregnant or breastfeeding women
  • subjects with known olfactory disorder
  • subjects with known neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infirmerie Protestante

Caluire-et-Cuire, 69300, France

RECRUITING

Study Officials

  • Frédéric FAURE, MD

    Infirmerie Protestante

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric FAURE, MD

CONTACT

Moustafa BENSAFI, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 20, 2017

Study Start

April 15, 2016

Primary Completion

March 15, 2022

Study Completion

April 15, 2022

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations