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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02901691
Other study ID # 2015-31
Secondary ID 2015-A01490-49
Status Recruiting
Phase N/A
First received September 12, 2016
Last updated September 12, 2016
Start date June 2016
Est. completion date June 2019

Study information

Verified date September 2016
Source Assistance Publique Hopitaux De Marseille
Contact Stéphane Roman, MD
Email stephane.roman@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2019
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 9 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
musical rhythmic stimulation


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numbers of words and phrases productions in the hearing impaired child. 3 months No