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RecruitingNCT06178276COraILUpdated Feb 16, 2024

Investigation of Neurophysiological Functioning During Oral Comprehension Task

An observational study in Learning, Language and Comprehension, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by University Hospital, Grenoble · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years to 35 Years
Sex
All
01

Study 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 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 :

  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.
02

Conditions studied

  • Learning
  • Language
  • Comprehension

Keywords

  • Language Learning
  • Oral comprehension
  • autonomic activity
  • brain activity
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

French learner in Italian language recruited at university

Inclusion criteria

  • French learner in Italian language
  • right-handed
  • affiliated to French social security
  • informed consent signed

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • A2 level

    Level of oral comprehension in italian language

    Diagnostic Test: behavior · Diagnostic Test: physiology · Diagnostic Test: imaging

  • B2 level

    Level of oral comprehension in italian language

    Diagnostic Test: behavior · Diagnostic Test: physiology · Diagnostic Test: imaging

Interventions

  • Diagnostic testbehavior

    behavioral measurements will be performed during the oral comprehension testing

  • Diagnostic testphysiology

    physiologic (autonomic) measurements will be performed during the oral comprehension testing

    Also known as: autonomic

  • Diagnostic testimaging

    central (brain) measurements will be performed during the oral comprehension testing

    Also known as: fMRI

06

What researchers measure

Primary outcomes

  1. Sympathetic activity

    ElectroDermal Activity (EDA) measured in µS

    Time frame: up to 3 months following the language profile completion

Secondary outcomes

  1. 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)

    Time frame: up to 3 months following the language profile completion

  2. Activated brain regions demonstrating brain activity

    fMRI brain imaging data will be analyzed using Statistical Parametric Mapping (SPM12).

    Time frame: up to 6 months following the language profile completion

  3. Correlations between sympathetic and parasympathetic activity

    correlation between EDA components measured in µS and relative power of the HF-HRV

    Time frame: up to 3 months following the language profile completion

  4. Interaction between sympathetic activity and brain activity

    Correlation of EDA (µS) with fMRI brain imaging data

    Time frame: up to 6 months following the acquisition of language profile

  5. Interaction between parasympathetic activity and brain activity

    Correlation of relative HF component of HRV with the fMRI brain imaging data

    Time frame: up to 6 months following the acquisition of language profile

  6. 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)

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

  7. 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

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

  8. Cognitive evaluation of short term memory

    WAIS4 subtest (measured by scores)

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — anonymised, processed data will be shared after publication acceptance on dedicated sites

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06178276
Lead sponsor
University Hospital, Grenoble
Collaborators
University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Dec 20, 2023
Start date
Feb 14, 2024
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Feb 16, 2024

Study contacts

Chantal M Delon-Martin, PhD
Contact
chantal.delon@univ-grenoble-alpes.fr
+33 4 56 52 05 89
Monica Masperi, PhD
Contact
monica.masperi@univ-grenoble-alpes.fr
+33 4 76 82 77 48
Triscia Biagiotti, Ms
study chair · University Grenoble Alpes

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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