Investigation of Neurophysiological Functioning During Oral Comprehension Task

Learning Clinical Trial

— COraIL  

Official title:

Investigation of Neurophysiological Functioning During Oral Comprehension Task. An Exploratory Study in Second Language (Italian) Learning in French Students Using Autonomic and Cerebral Investigation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178276
• Other study ID #: 38RC23.0309
• Secondary ID: 2023-A01939-36
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Grenoble
• Contact: Chantal M Delon-Martin, PhD
• Phone: +33 4 56 52 05 89
• Email: chantal.delon[@]univ-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The oral comprehension (OC) of a second language (L2) involves different cognitive processes, specially during the learning phase. This study aims at investigating the neurophysiological functioning of different steps involved in this oral understanding.

Description:

Here, the investigators seek for the different neurophysiological processes involved in OC according to the level of understanding (2 levels) and its different phases (fluid, hindered and metacognitive feedback).

This study therefore requires three different research methodologies :

1. an interactive system dedicated to the boundary delimitations of obstacles during OC

2. an investigation of the autonomic nervous system responses (measurement of electrodermal activity and heart rate variability) that will likely occur differently during different phases of the OC process

3. an investigation of the central responses (through fMRI technique), coupled with autonomous responses, that will identify the different neural networks in the different stages of the OC process.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• French learner in Italian language

• right-handed

• affiliated to French social security

• informed consent signed

Exclusion Criteria:

• pregnant woman

• audiologic pathology impacting the capacity of hearing

• neurologic or psychiatric pathology that may interfere with oral comprehension

• learning disability (for instance: dyslexia)

• contra-indication to MRI and to EDA acquisition

Related Conditions & MeSH terms

• Comprehension
• Language
• Learning

Intervention

Diagnostic Test:
• behavior
behavioral measurements will be performed during the oral comprehension testing
• physiology
physiologic (autonomic) measurements will be performed during the oral comprehension testing
• imaging
central (brain) measurements will be performed during the oral comprehension testing

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France, University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathetic activity	ElectroDermal Activity (EDA) measured in µS	up to 3 months following the language profile completion
Secondary	Parasympathetic activity	Heart Rate Variability (HRV) measured using the relative power of the high-frequency (HF) component of the HRV (in % of the total power)	up to 3 months following the language profile completion
Secondary	Activated brain regions demonstrating brain activity	fMRI brain imaging data will be analyzed using Statistical Parametric Mapping (SPM12).	up to 6 months following the language profile completion
Secondary	Correlations between sympathetic and parasympathetic activity	correlation between EDA components measured in µS and relative power of the HF-HRV	up to 3 months following the language profile completion
Secondary	Interaction between sympathetic activity and brain activity	Correlation of EDA (µS) with fMRI brain imaging data	up to 6 months following the acquisition of language profile
Secondary	Interaction between parasympathetic activity and brain activity	Correlation of relative HF component of HRV with the fMRI brain imaging data	up to 6 months following the acquisition of language profile
Secondary	Linguistic evaluation	Linguistic processes are assessed by performance score on the following tests: verbal fluency test in first language (number of items found in 1 min); verbal fluency test in second language (number of items found in 1 min)	up to 1 month following the acquisition of language profile
Secondary	Cognitive evaluation of executive functions	Cognitive evaluation assessed by the following tests: Trail Making Test (TMT-A and TMT-B) scores. Time duration (in seconds) for each subtest. Shortest duration meaning efficient executive functions	up to 1 month following the acquisition of language profile
Secondary	Cognitive evaluation of short term memory	WAIS4 subtest (measured by scores)	up to 1 month following the acquisition of language profile