LearningCOraILNCT06178276
Investigation of Neurophysiological Functioning During Oral Comprehension Task
An observational study of Learning and Language, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning, Language, Comprehension
- What is being tested?
- behavior, physiology and imaging
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2024to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: French learner in Italian language recruited at university
Who may be able to join
- French learner in Italian language
- right-handed
- affiliated to French social security
- informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38700
Chantal M Delon-Martin, PhD, +33 4 56 52 05 89, chantal.delon@univ-grenoble-alpes.fr
Monica Masperi, PhD, +33 4 76 82 77 48, monica.masperi@univ-grenoble-alpes.fr
About this study
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
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.
Read the 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 :
- an interactive system dedicated to the boundary delimitations of obstacles during OC
- 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
- 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.
- Conditions
- Learning, Language, Comprehension
- Being tested
- behavior, physiology, imaging
- Keywords
- Language Learning, Oral comprehension, autonomic activity, brain activity
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behaviorDiagnostic test
behavioral measurements will be performed during the oral comprehension testing
physiologyDiagnostic test
Also called autonomic
physiologic (autonomic) measurements will be performed during the oral comprehension testing
imagingDiagnostic test
Also called fMRI
central (brain) measurements will be performed during the oral comprehension testing
| Study group | Role | What they receive |
|---|---|---|
| A2 level | Level of oral comprehension in italian language Receives: Diagnostic Test: behavior; Diagnostic Test: physiology; Diagnostic Test: imaging | |
| B2 level | Level of oral comprehension in italian language Receives: Diagnostic Test: behavior; Diagnostic Test: physiology; Diagnostic Test: imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic activity
ElectroDermal Activity (EDA) measured in µS
Measured: up to 3 months following the language profile completion
Secondary outcomes (8)
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)
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: up to 1 month following the acquisition of language profile
Cognitive evaluation of short term memory
WAIS4 subtest (measured by scores)
Measured: up to 1 month following the acquisition of language profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start14 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LearningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Triscia Biagiotti, Ms, Study chair, University Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178276
- Sponsor's protocol ID
- 38RC23.0309
- Other IDs
- 2023-A01939-36
- Acronym
- COraIL
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymised, processed data will be shared after publication acceptance on dedicated sites
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06178276
- Acronym / sponsor ID
- COraIL / 38RC23.0309
- Conditions
- Learning, Language, Comprehension
- Keywords
- Language Learning, Oral comprehension, autonomic activity, brain activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- an interactive system dedicated to the boundary delimitations of obstacles during OC
- 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
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A2 level | – | Diagnostic Test: behavior, Diagnostic Test: physiology, Diagnostic Test: imagingLevel of oral comprehension in italian language |
| B2 level | – | Diagnostic Test: behavior, Diagnostic Test: physiology, Diagnostic Test: imagingLevel of oral comprehension in italian language |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- French learner in Italian language recruited at university
Key inclusion criteria (4 listed)
- French learner in Italian language
- right-handed
- affiliated to French social security
- informed consent signed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behaviorbehavioral measurements will be performed during the oral comprehension testing | Diagnostic test | A2 level, B2 level |
| physiologyAlso: autonomicphysiologic (autonomic) measurements will be performed during the oral comprehension testing | Diagnostic test | A2 level, B2 level |
| imagingAlso: fMRIcentral (brain) measurements will be performed during the oral comprehension testing | Diagnostic test | A2 level, B2 level |
Primary outcome
Sympathetic activity
Time frame: up to 3 months following the language profile completion
ElectroDermal Activity (EDA) measured in µS
8 secondary outcomes
Parasympathetic activity
Time frame: 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
Correlations between sympathetic and parasympathetic activity
Time frame: 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
Interaction between parasympathetic activity and brain activity
Time frame: up to 6 months following the acquisition of language profile
Linguistic evaluation
Time frame: 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 of short term memory
Time frame: up to 1 month following the acquisition of language profile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Undecided. anonymised, processed data will be shared after publication acceptance on dedicated sites
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Triscia Biagiotti, Ms study chair
University Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Learning and Language, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal M Delon-Martin, PhD (+33 4 56 52 05 89, chantal.delon@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic activity (time frame: up to 3 months following the language profile completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.