Investigation of Neurophysiological Functioning During Oral Comprehension Task (COraIL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Learning; Language; Comprehension
• Intervention / Treatment: Diagnostic test: behavior; Diagnostic test: physiology; Diagnostic test: imaging

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Chantal M Delon-Martin, PhD; Phone Number: +33 4 56 52 05 89; Email: chantal.delon@univ-grenoble-alpes.fr
• Study Contact Backup: Name: Monica Masperi, PhD; Phone Number: +33 4 76 82 77 48; Email: monica.masperi@univ-grenoble-alpes.fr

Study Locations

• France
  • Grenoble, France, 38700
    • Recruiting
    • University Hospital Grenoble
    • Contact: Chantal M Delon-Martin, PhD; Phone Number: +33 4 56 52 05 89; Email: chantal.delon@univ-grenoble-alpes.fr
    • Contact: Monica Masperi, PhD; Phone Number: +33 4 76 82 77 48; Email: monica.masperi@univ-grenoble-alpes.fr
    • Sub-Investigator: Triscia Biagiotti, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

French learner in Italian language recruited at university

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A2 level; Level of oral comprehension in italian language	Diagnostic test: behavior; behavioral measurements will be performed during the oral comprehension testing; Diagnostic test: physiology; physiologic (autonomic) measurements will be performed during the oral comprehension testing; Other Names: autonomic; Diagnostic test: imaging; central (brain) measurements will be performed during the oral comprehension testing; Other Names: fMRI
B2 level; Level of oral comprehension in italian language	Diagnostic test: behavior; behavioral measurements will be performed during the oral comprehension testing; Diagnostic test: physiology; physiologic (autonomic) measurements will be performed during the oral comprehension testing; Other Names: autonomic; Diagnostic test: imaging; central (brain) measurements will be performed during the oral comprehension testing; Other Names: fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathetic activity	ElectroDermal Activity (EDA) measured in µS	up to 3 months following the language profile completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Cognitive evaluation of short term memory	WAIS4 subtest (measured by scores)	up to 1 month following the acquisition of language profile

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University Grenoble Alps
• Investigators: Study Chair: Triscia Biagiotti, Ms, University Grenoble alpes

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: brain activity; autonomic activity; Language Learning; Oral comprehension
• Other Study ID Numbers: 38RC23.0309; 2023-A01939-36 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: anonymised, processed data will be shared after publication acceptance on dedicated sites

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No