AzTrials
AzTrials

Deafness; Perception, BilateralPLASMODYNCT02632214

Plasticity and Cross-modal Interactions in Profoundly Deaf Adults

A study testing fMRI measure in people with Deafness; Perception, Bilateral, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Deafness; Perception, Bilateral
What is being tested?
fMRI measure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteFrance
Study dates
Apr 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Cardiac or respiratory trouble
  • For Deaf participants:
  • unilateral hearing loss
  • cochlear implant

Trial locations and contacts

1 site in 1 country.

France1 site
  • plateforme IRMage

    Grenoble, 38000

Other trials in France

About this study

Official title: Plasticity and Cross-modal Interactions for Oral Communication in Profoundly Deaf Adults

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.

Read the detailed description

A rightward asymmetry during face processing is well documented in hearing participants, in particular in the Fusiform Face Area, a cortical area underlying face processing. This rightward asymmetry seems to be very robust, present even with inverted faces or line drawings, and is already present at five years of age. If the brain asymmetry for face processing emerges during development, early deprivation or dramatic differences the infant's experience with the world should affect it. For example, infants treated for bilateral congenital cataracts after 7 weeks of age, who are deprived of patterned visual input for this duration, fail to develop some of the aspects associated with typical adult levels of face recognition. Non visual early deprivation can also affect the development of visual abilities. Several studies showed that deaf participants could detect targets at larger eccentricities, thus indicating larger visual field . Furthermore, better abilities have been found in deaf participants for the detection of motion, in particular in the visual periphery . Higher-level visual abilities have also been shown to be modified by early deafness, such as visual imagery (image generation, or rotation) or the processing of faces . Using the Benton Test of Facial Recognition, a previous study tested the recognition of individual faces in deaf participants. They obtained better scores than hearing non signers, but only in a difficult condition, in which faces were shadowed. This enhanced processing in deaf people could thus concern very particular aspects of face processing; it was found that deaf and normal hearing differed only by the detection of subtle facial features. Investigating configural processing during face perception, it was found an increased dependency on this mode of processing in deaf participants.

If visual processing is affected by early deafness, what about visual asymmetries? Several experimental studies examining hemispheric asymmetry in congenitally deaf individuals found that it differs from the one observed in hearing individuals . Concerning face processing, few studies investigated hemispheric lateralization during the perception of faces in deaf people. When presenting briefly unfamiliar faces in either the left or right visual field and no differences between deaf and hearing participants were found. In a previous experiment, using chimeric faces (faces vertically split into two different parts, ie half male, half female) it was found a reduction of leftward asymmetry for face processing in deaf participants during a gender categorization task.

The aim of the present study is to broaden the knowledge about asymmetry for face processing in deaf people, by evaluating if this reduction of asymmetry observed at the behavioral level results from a reduction of cerebral asymmetry at the level of Fusiform Face Area.

Deaf participants and normal hearing controls will be presented face stimuli, composed of either chimeric male/female and female/male faces, entire faces or entire face presented in divided visual field, to investigate Fusiform Face Area asymmetry in these two groups. Participants will lie in an fMRI scanner, and their cerebral activity will be recorded while they perform a gender categorization task on our face stimuli.

Being tested
fMRI measure
Keywords
Face processing, asymmetry, deaf, fMRI
Medical subject headings
Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fMRI measureOther

Study groups in NCT02632214
Study groupRoleWhat they receive
DeafExperimentalGroup of early profound deaf participants fMRI measure
Receives: Other: fMRI measure
Hearing signersExperimentalGroup of hearing signer controls fMRI measure
Receives: Other: fMRI measure
Hearing non signersSham comparatorGroup of hearing non signer controls fMRI measure
Receives: Other: fMRI measure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cerebral activity (fMRI measure)

    Measured: Time 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02632214
Sponsor's protocol ID
2014-A00088-39
Acronym
PLASMODY
Status last verified
Jan 2017
First submitted
11 Aug 2015
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing fMRI measure in people with Deafness; Perception, Bilateral, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cerebral activity (fMRI measure) (time frame: Time 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in