Investigation of Neurophysiological Functioning During Oral Comprehension Task (COraIL)

February 15, 2024 updated by: University Hospital, Grenoble

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sympathetic activity
Time Frame: up to 3 months following the language profile completion
ElectroDermal Activity (EDA) measured in µS
up to 3 months following the language profile completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parasympathetic activity
Time Frame: up to 3 months following the language profile completion
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
Time Frame: up to 6 months following the language profile completion
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
Time Frame: up to 3 months following the language profile completion
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
Time Frame: up to 6 months following the acquisition of language profile
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
Time Frame: up to 6 months following the acquisition of language profile
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
Time Frame: up to 1 month following the acquisition of language profile

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
Time Frame: up to 1 month following the acquisition of language profile

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
Time Frame: up to 1 month following the acquisition of language profile
WAIS4 subtest (measured by scores)
up to 1 month following the acquisition of language profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
University Grenoble Alps

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Triscia Biagiotti, Ms, University Grenoble alpes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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