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Study of Neurologic Development of Temporal Voice Area (TVA) in Deaf Infant (Implaneuro)

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ClinicalTrials.gov Identifier: NCT02379611
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : March 5, 2015
Last Update Posted : August 24, 2016
Sponsor:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

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). This fNIRS examination measures the modifications in brain blood flow during the listening of human voice sound and environmental sound.


Condition or disease Intervention/treatment Phase
Profound Congenital Deaf Children Implanted Procedure: fNIRS (Functional Near Infrared Spectroscopy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Trial Comparing Neurologic Development of Temporal Voice Area in Cochlear Implanted Deaf Infant and in Normally Hearing Infant.
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: normally hearing children Procedure: 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.

Experimental: Congenital profound deaf children Procedure: 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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Brain blood flow by means of fNIRS (Functional Near infrared Spectroscopy) [ Time Frame: 24 months of age ]


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Ages Eligible for Study:   up to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 13 months old child
  • normal otoscopic examination
  • Parents speaks French
  • Written consent from both parents

Exclusion Criteria:

  • acquired hearing loss,
  • intensive care unit,
  • neurologic disorder,
  • pre-term baby

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379611


Contacts
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Contact: Natalie Loundon, MD +33 1 44 49 40 00 natalie.loundon@nck.aphp.fr
Contact: Arnaud Coez, Pharm D, PhD +33 1 42 96 87 70 acoez@noos.fr

Locations
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France
Hôpital Necker Enfants malades Service d'ORL Recruiting
Paris, France, 75015
Contact: Natalie Loundon, MD    +33 1 44 49 40 00 ext +33    natalie.loundon@aphp.fr   
Contact: Marion Blanchard, MD    01 71 39 67 92 ext +33    marion.blanchard@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Centre National de la Recherche Scientifique, France
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
Investigators
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Principal Investigator: Natalie Loundon, MD Assistance Publique

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02379611    
Other Study ID Numbers: P130706
HAO13016 ( Other Identifier: Assistance Publique )
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016