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.
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.
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.
- Conditions
- Deafness; Perception, Bilateral
- 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 group | Role | What they receive |
|---|---|---|
| Deaf | Experimental | Group of early profound deaf participants fMRI measure Receives: Other: fMRI measure |
| Hearing signers | Experimental | Group of hearing signer controls fMRI measure Receives: Other: fMRI measure |
| Hearing non signers | Sham comparator | Group 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.
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.
- First posted16 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness; Perception, BilateralStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity and Cross-modal Interactions for Oral Communication in Profoundly Deaf Adults
- ClinicalTrials.gov ID
- NCT02632214
- Acronym / sponsor ID
- PLASMODY / 2014-A00088-39
- Conditions
- Deafness; Perception, Bilateral
- Keywords
- Face processing, asymmetry, deaf, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deaf | Experimental | Other: fMRI measureGroup of early profound deaf participants fMRI measure |
| Hearing signers | Experimental | Other: fMRI measureGroup of hearing signer controls fMRI measure |
| Hearing non signers | Sham comparator | Other: fMRI measureGroup of hearing non signer controls fMRI measure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI measure | Other | Deaf, Hearing non signers, Hearing signers |
Primary outcome
cerebral activity (fMRI measure)
Time frame: Time 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Related trials for Deafness; Perception, Bilateral
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Hearing Loss, Bilateral Sensorineural
RecruitingPhase 3
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Sensorineural Hearing Loss, Bilateral
Active, not recruiting
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Hearing Loss, Bilateral Sensorineural
RecruitingPhase 1/2
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.