RHYTHMIC STIMULUS EFFECTS ON NEURONAL OSCILLATORY ACTIVITY AND SPEACHES CAPABILITIES IN DEAF CHILDREN
Primary Purpose
Children Deafness
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
musical rhythmic stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Children Deafness
Eligibility Criteria
Inclusion Criteria:
- prélingual paired deaf or implanted cochlear children.
Exclusion Criteria:
- Childreen with other major disabilities and associated disorders.
- Clidren with failure to understand instructions either directly oral or sign language.
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Deaf children
healthy volonteer children
Arm Description
Outcomes
Primary Outcome Measures
Numbers of words and phrases productions in the hearing impaired child.
Secondary Outcome Measures
Full Information
NCT ID
NCT02901691
First Posted
September 12, 2016
Last Updated
September 12, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02901691
Brief Title
RHYTHMIC STIMULUS EFFECTS ON NEURONAL OSCILLATORY ACTIVITY AND SPEACHES CAPABILITIES IN DEAF CHILDREN
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The deaf children showed deficits in speech processing and temporality. They badly apprehend temporal concepts and perceptions of deficit so the acoustic phenomena marking the time course linguistically. Their prediction capabilities and anticipation multisensory events are thereby affected, thus impacting their ability to adapt to multiple and complex interaction possibilities that arise during a conversation.The project aim it is to measure the impact of a musical rhythmic stimulation of neuronal activity and the temporal prediction capabilities of older deaf children 5 to 8 years and its impact on their language skills in a conversational task. A matched control group of age will be examined for each of the proposed tasks.
We first measure the capacity to anticipate a situation of language interaction. For this purpose, we will use an alternate naming paradigm with a virtual partner, already developed and tested in children with normal hearing. This paradigm approaches the conversational situation while allowing control of the time parameter of speech (speed of trade) and by controlling the bias (temporal) inherent linguistic programming difficulties of children in a spontaneous conversation situations .
Then we will couple behavioral measurements with measurements of eye movements and the electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task already developed for normal hearing children. This task will allow us firstly to analyze the anticipation level of speaking turns by analyzing eye movements (which "precedes" the speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of anticipatory processes and convergence in conversational interaction will also be studied using cortico-cortical coherence techniques to assess the dynamics of connectivity between remote networks (system here auditory and motor system).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children Deafness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deaf children
Arm Type
Experimental
Arm Title
healthy volonteer children
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
musical rhythmic stimulation
Primary Outcome Measure Information:
Title
Numbers of words and phrases productions in the hearing impaired child.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
prélingual paired deaf or implanted cochlear children.
Exclusion Criteria:
Childreen with other major disabilities and associated disorders.
Clidren with failure to understand instructions either directly oral or sign language.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Roman, MD
Email
stephane.roman@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stéphane ROMAN, MD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane ROMAN, MD
Email
stephane.roman@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RHYTHMIC STIMULUS EFFECTS ON NEURONAL OSCILLATORY ACTIVITY AND SPEACHES CAPABILITIES IN DEAF CHILDREN
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