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Not yet recruiting NCT06282289

Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants

No phase Interventional Speech

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetoencephalography (MEG), Cognition development questionnaire.
Who it may be relevant to
Registry conditions: Speech. Basic parameters: 6 months — 10 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this study is to investigate the preferential responses of speech neural systems in infants. The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary). Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz.

Interventions

  • Behavioral Magnetoencephalography (MEG)
    Stimuli will be presented binaurally through headphones at 60 decibel sound pressure level (dB SPL). Conditions are presented in a pseudo-random order with an inter-stimulus interval of \~800 ms on average (range: 600 ms to 1000 ms). The duration of the stimuli is fixed: 2 seconds, in order to guarantee a minimum number of cycles.
  • Other Cognition development questionnaire
    Computerised questionnaires completed by parents

Primary outcome measures

  • Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age. [Time frame: at 10-months, 6-months and 18-months of age]
Secondary outcome measures (2)
  • The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs [Time frame: at 10- and 6-months of age]
  • The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs [Time frame: at 10- and 6-months of age]

Eligibility criteria

Inclusion criteria

  • be 6 or 10 months old (+/- 2 weeks)
  • have received age-appropriate information on the experiment
  • their legal guardians have received appropriate information and given their oral consent.

Exclusion criteria

  • A neurological disorder (visual, auditory, motor, executive)
  • Developmental delay

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06282289 · 2023-077 · 2023-A01798-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗