Profound Congenital Deaf Children ImplantedImplaneuroNCT02379611
Study of Neurologic Development of Temporal Voice Area (TVA) in Deaf Infant
A study testing fNIRS (Functional Near Infrared Spectroscopy) in people with Profound Congenital Deaf Children Implanted, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted profound congenital deaf infant would be different to the development of a normally hearing infant. Read more about this study
- Who is it for?
- Ages Up to 13 months
- Conditions the study is for
- Profound Congenital Deaf Children Implanted
- What is being tested?
- fNIRS (Functional Near Infrared Spectroscopy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2015to 21 Oct 2020
- 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 Up to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child between 11 and 13 months at the time of the first fNIRS imaging testless
- Isolated congenital bilateral profound deafness
- Bilateral conventional hearing equipment between 2 and 10 months of life
- Rehabilitation project by cochlear implantation between 12 and 18 months accepted by parents
- French speaking parents
- Normal eardrums on otoscopy
Show all 21Show fewer
- Signature of consent by both parents or by the sole parent with parental authority
- Beneficiary of a french social security (excluding AME)
- Any infant, followed in ORL consultation for any reason other than deafness, aged between 11 and 13 months at the time of the first fNIRS imaging examination.
- normal otoscopic examination
- Parents speaks French
- Signature of consent by both parents or by the sole parent with parental authority
- Non inclusion criteria deaf infants:
- Stay in intensive care unit
- Premature birth
- Proven neuro-pediatric disorder
- Acquired deafness
- Non inclusion criteria for hearing infants:
- Stay in intensive care unit
- Premature birth
- Proven neuro-pediatric disorder
Who cannot join
- Acquired deafness during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Comparing Neurologic Development of Temporal Voice Area in Cochlear Implanted Deaf Infant and in Normally Hearing Infant.
Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted profound congenital deaf infant would be different to the development of a normally hearing infant.
At 24 months of age, the neurologic development of TVA of deaf infant implanted before the age of 18 months would be similar to the development of a normally hearing infant.
Read more
Main aim The main aim of the research is to study, by means of functional near infrared spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month) in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital deaf children implanted before the age of 18 months.
Main outcome Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type. Comparison of the results between groups at 24 months of age +/- 1 month allows to analyse eventual differences.
Secondary aims and outcomes To study by means of functional near infrared spectroscopy the neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a group of normally hearing infant and in a group of profound congenital deaf infant wearing a standard hearing device between the age of 11 and 13 months and who will receive a cochlear implant between 12 and 18 months of age.
To study the association between fNIRS data and clinical data of the evaluation of comprehension of the spoken language at 24 months of age.
Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old children will be included during a medical consultation in the ENT department of Necker hospital after complete information of both parents. Written consent of both parents will be required. An audiophonological checking will be done.
Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). A fNIRS examination will be programmed at 36 months of age (+/- 1 month) for patinets included in the first year of the study.
This fNIRS examination measures the modifications in brain blood flow during the listening of human voice sound and environmental sound.
Read the detailed description
One or two among a thousand new-born will require hearing device or cochlear implantation before the age of 4 years to correct a hearing loss. Without any appropriate hearing stimulation, some brain area, including temporal voice area (TVA), will remodel. But this remodeling process is a deleterious phenomenon in case of future cochlear implantation. Therefore it seems to be crucial to better understand the impact of hearing loss on neurologic development of TVA in infant.
Main aim and outcome:
Main aim of the research is to compare cortical activation in the TVA at 24 months of age (+/- 1 month), by means of the measure of hemoglobin and/or desoxyhemoglobin concentration in the TVA during listening of human voice sound compared to non-voice sound (environmental sounds) (fNIRS method):
- in normally hearing infants
- in profound congenital deaf infants who received a standard auditory device before the age of 10 months and who were implanted between 12 and 18 months of age.
Comparison of the results in these two groups at 24 months +/- 1 month will allow to evaluate the impact of hearing loss and of its rehabilitation by means of standard hearing device and then by cochlear implant on neurologic development of the TVA in infant.
Main outcome is the recording of a difference in the measure of hemoglobin and/or desoxyhemoglobin concentration during listening of human voice sounds compared to environmental sounds in the TVA, in both groups of infants at 24 months old (+/- 1 month). A difference in localization of activations in the "deaf" group would suggest a modification of the neuro-development of the TVA due to the hearing loss. On the contrary, a similar localization of activated areas would suggest a "picking up" of the neuro-development of TVA due to the correction of hearing loss by means of an auditory device.
Secondary aims and outcomes
Compare cortical activation in the TVA at 12 months of age (+/- 1 month) by means of the measure of hemoglobin and/or desoxyhemoglobin concentration in the TVA during listening of human voice sounds compared to environmental sounds:
- in normally hearing infants
- in profound congenital deaf infants who received a standard auditory device before the age of 10 months and who were implanted between 12 and 18 months of age.
Secondary outcome is the recording of a difference in the measure of hemoglobin and / or desoxyhemoglobin concentration in the TVA during listening of human voice sounds compared to environmental sounds in both groups of infants at 12 months of age (+/- 1 month).
Comparison of the results in these two groups at 12 months +/- 1 month will allow to evaluate the impact of hearing loss and of its rehabilitation by means of standard hearing device and then by cochlear implant on neurologic development of the TVA in infant.
Comparison of results obtained at 12 months (+/- 1 month) and 24 months (+/- 1 month) of age in both groups will allow the study of neurological development of TVA in normally hearing infants and in deaf infants wearing an auditory device for a period of one year.
Study association between development of oral communication, measured by means of questionnaire of evaluation of communication development and of comprehension of oral language in infant, and activation of TVA at 24 months of age by means of fNIRS.
- Being tested
- fNIRS (Functional Near Infrared Spectroscopy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS (Functional Near Infrared Spectroscopy)Procedure or surgery
fNIRS is a non-invasive imaging method involving the quantification of chromophore concentration resolved from the measurement of near infrared (NIR) light attenuation, temporal or phasic changes. NIR spectrum light takes advantage of the optical window in which skin, tissue, and bone are mostly transparent to NIR light in the spectrum of 700-900 nm, while hemoglobin (Hb) and deoxygenated-hemoglobin (deoxy-Hb) are stronger absorbers of light. Differences in the absorption spectra of deoxy-Hb and oxy-Hb allow the measurement of relative changes in hemoglobin concentration through the use of light attenuation at multiple wavelengths.
| Study group | Role | What they receive |
|---|---|---|
| normally hearing children | Active comparator | Not described Receives: Procedure: fNIRS (Functional Near Infrared Spectroscopy) |
| Congenital profound deaf children | Experimental | Not described Receives: Procedure: fNIRS (Functional Near Infrared Spectroscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 24 months of age.
Measured: 24 months of age
Secondary outcomes (2)
Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 12 months of age.
Measured: 12 months of age
Brain blood flow by means of fNIRS (Functional Near infrared Spectroscopy)
Measured: 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start2 Sep 2015
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Profound Congenital Deaf Children ImplantedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
- Investigators
- Natalie Loundon, MD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379611
- Sponsor's protocol ID
- P130706
- Other IDs
- HAO13016
- Acronym
- Implaneuro
- Status last verified
- Oct 2021
- First submitted
- 19 Dec 2014
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing Neurologic Development of Temporal Voice Area in Cochlear Implanted Deaf Infant and in Normally Hearing Infant.
- ClinicalTrials.gov ID
- NCT02379611
- Acronym / sponsor ID
- Implaneuro / P130706
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 5 Mar 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.
Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted profound congenital deaf infant would be different to the development of a normally hearing infant.
At 24 months of age, the neurologic development of TVA of deaf infant implanted before the age of 18 months would be similar to the development of a normally hearing infant.
Main aim The main aim of the research is to study, by means of functional near infrared spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month) in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital deaf children implanted before the age of 18 months.
Main outcome Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type. Comparison of the results between groups at 24 months of age +/- 1 month allows to analyse eventual differences.
Secondary aims and outcomes To study by means of functional near infrared spectroscopy the neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a group of normally hearing infant and in a group of profound congenital deaf infant wearing a standard hearing device between the age of 11 and 13 months and who will receive a cochlear implant between 12 and 18 months of age.
To study the association between fNIRS data and clinical data of the evaluation of comprehension of the spoken language at 24 months of age.
Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old children will be included during a medical consultation in the ENT department of Necker hospital after complete information of both parents. Written consent of both parents will be required. An audiophonological checking will be done.
Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). A fNIRS examination will be programmed at 36 months of age (+/- 1 month) for patinets included in the first year of the study.
This fNIRS examination measures the modifications in brain blood flow during the listening of human voice sound and environmental sound.
Detailed description
One or two among a thousand new-born will require hearing device or cochlear implantation before the age of 4 years to correct a hearing loss. Without any appropriate hearing stimulation, some brain area, including temporal voice area (TVA), will remodel. But this remodeling process is a deleterious phenomenon in case of future cochlear implantation. Therefore it seems to be crucial to better understand the impact of hearing loss on neurologic development of TVA in infant.
Main aim and outcome:
Main aim of the research is to compare cortical activation in the TVA at 24 months of age (+/- 1 month), by means of the measure of hemoglobin and/or desoxyhemoglobin concentration in the TVA during listening of human voice sound compared to non-voice sound (environmental sounds) (fNIRS method):
- in normally hearing infants
- in profound congenital deaf infants who received a standard auditory device before the age of 10 months and who were implanted between 12 and 18 months of age.
Comparison of the results in these two groups at 24 months +/- 1 month will allow to evaluate the impact of hearing loss and of its rehabilitation by means of standard hearing device and then by cochlear implant on neurologic development of the TVA in infant.
Main outcome is the recording of a difference in the measure of hemoglobin and/or desoxyhemoglobin concentration during listening of human voice sounds compared to environmental sounds in the TVA, in both groups of infants at 24 months old (+/- 1 month). A difference in localization of activations in the "deaf" group would suggest a modification of the neuro-development of the TVA due to the hearing loss. On the contrary, a similar localization of activated areas would suggest a "picking up" of the neuro-development of TVA due to the correction of hearing loss by means of an auditory device.
Secondary aims and outcomes
Compare cortical activation in the TVA at 12 months of age (+/- 1 month) by means of the measure of hemoglobin and/or desoxyhemoglobin concentration in the TVA during listening of human voice sounds compared to environmental sounds:
- in normally hearing infants
- in profound congenital deaf infants who received a standard auditory device before the age of 10 months and who were implanted between 12 and 18 months of age.
Secondary outcome is the recording of a difference in the measure of hemoglobin and / or desoxyhemoglobin concentration in the TVA during listening of human voice sounds compared to environmental sounds in both groups of infants at 12 months of age (+/- 1 month).
Comparison of the results in these two groups at 12 months +/- 1 month will allow to evaluate the impact of hearing loss and of its rehabilitation by means of standard hearing device and then by cochlear implant on neurologic development of the TVA in infant.
Comparison of results obtained at 12 months (+/- 1 month) and 24 months (+/- 1 month) of age in both groups will allow the study of neurological development of TVA in normally hearing infants and in deaf infants wearing an auditory device for a period of one year.
Study association between development of oral communication, measured by means of questionnaire of evaluation of communication development and of comprehension of oral language in infant, and activation of TVA at 24 months of age by means of fNIRS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normally hearing children | Active comparator | Procedure: fNIRS (Functional Near Infrared Spectroscopy) |
| Congenital profound deaf children | Experimental | Procedure: fNIRS (Functional Near Infrared Spectroscopy) |
Who may qualify
- Ages
- Up to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- child between 11 and 13 months at the time of the first fNIRS imaging testless
- Isolated congenital bilateral profound deafness
- Bilateral conventional hearing equipment between 2 and 10 months of life
- Rehabilitation project by cochlear implantation between 12 and 18 months accepted by parents
- French speaking parents
Key exclusion criteria (1 listed)
- Acquired deafness during study
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 |
|---|---|---|
| fNIRS (Functional Near Infrared Spectroscopy)fNIRS is a non-invasive imaging method involving the quantification of chromophore concentration resolved from the measurement of near infrared (NIR) light attenuation, temporal or phasic changes. NIR spectrum light takes advantage of the optical window in which skin, tissue, and bone are mostly transparent to NIR light in the spectrum of 700-900 nm, while hemoglobin (Hb) and deoxygenated-hemoglobin (deoxy-Hb) are stronger absorbers of light. Differences in the absorption spectra of deoxy-Hb and oxy-Hb allow the measurement of relative changes in hemoglobin concentration through the use of light attenuation at multiple wavelengths. | Procedure or surgery | Congenital profound deaf children, normally hearing children |
Primary outcome
Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 24 months of age.
Time frame: 24 months of age
2 secondary outcomes
Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 12 months of age.
Time frame: 12 months of age
Brain blood flow by means of fNIRS (Functional Near infrared Spectroscopy)
Time frame: 24 months of age
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 26 Oct 2021.
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.
Natalie Loundon, MD principal investigator
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fNIRS (Functional Near Infrared Spectroscopy) in people with Profound Congenital Deaf Children Implanted, run by Assistance Publique - Hôpitaux de Paris 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 21 inclusion and 1 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 26 Oct 2021. 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. 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?
Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 24 months of age. (time frame: 24 months of age). 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 26 Oct 2021.