NCT02632214

Brief Summary

The aim of this study is to evaluate cerebral asymmetry for face processing in a group of profoundly deaf participants and a group of hearing controls by the mean of fMRI measure. To this end, we present chimeric faces (faces split into different halves), entire faces, or faces presented in divided visual field, and subjects perform a gender categorization task while lying in a fMRI scanner. It is expected to find a reduced cerebral asymmetry in the Fusiform Face Area in deaf in comparison with hearing participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

August 11, 2015

Last Update Submit

January 17, 2017

Conditions

Keywords

Face processingasymmetrydeaffMRI

Outcome Measures

Primary Outcomes (1)

  • cerebral activity (fMRI measure)

    Time 0

Study Arms (3)

Deaf

EXPERIMENTAL

Group of early profound deaf participants fMRI measure

Other: fMRI measure

Hearing signers

EXPERIMENTAL

Group of hearing signer controls fMRI measure

Other: fMRI measure

Hearing non signers

SHAM COMPARATOR

Group of hearing non signer controls fMRI measure

Other: fMRI measure

Interventions

DeafHearing non signersHearing signers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Consent Form signed
  • Medical exam performed before entering in to the scanner
  • age between 18 and 60 years
  • Absence of neurological and/or psychiatric troubles
  • Normal or corrected vision
  • Right handed
  • For Deaf participants:
  • Bilateral hearing loss 80 dB or more
  • Hearing loss before 2 years of age
  • use of French Sign Language
  • For Hearing participants - signers:
  • Absence of hearing loss
  • Use of French sign Language (Bilingual)
  • For Hearing participants - non signers:
  • Absence of hearing loss

You may not qualify if:

  • Pregnant women, mothers who suckle, minors
  • Presence of metal implants (cardiac implants, bone implants, auditory implants...),
  • Presence of skin implants: not removable body piercings, tattoos, not removable jewels
  • Claustrophobia
  • Visual impairment without correction
  • Neurological/Psychiatric disorder
  • Cardiac or respiratory trouble
  • For Deaf participants:
  • unilateral hearing loss
  • cochlear implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

plateforme IRMage

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

December 16, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations