- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185102
Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.
Study Overview
Detailed Description
In a medical context based on the solicitation of various cognitive functions, it is essential to be able to modulate the level of difficulty of the task, to maintain a constant level of mental workload while preserving the playful aspect of the activity. This must be sufficient to maintain the person's involvement without inducing too high a mental workload.
However, currently, there is no standardized model of variation of mental workload for cognitive tasks that could be used to modulate the difficulty. The present study is therefore part of this context and concerns the identification of the mental workload during tasks requiring cognitive functions such as memory or attention.
Further this study will allow to adapt in real time the difficulty of virtual tasks to the mental workload of people. In other words, to have a universal brain decoder of the mental workload.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nantes, France, 44093
- Nantes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age> 20 years old and <50 years old
- French-speaking men or women
- Fluent in French (native speaker or fluent)
- Hold at least a baccalaureate +2
- Right-handed
- Having normal or corrected to normal vision
- Having normal or corrected to normal hearing
Exclusion Criteria:
- Minors
- Adults under guardianship or curatorship
- Non-French speakers
- Sleep debt at the time of the experience
- Daltonism
- Vision and hearing uncorrected to normal
- Pregnant or breastfeeding women
- History of associated cranial trauma or any other neurological pathology altering the cerebral sensory-motor system or the cognitive capacities and higher functions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive tasks
Electroencephalographic signals registration during different levels of difficulty of three tasks requiring very distinct cognitive functions: the updating of verbal memory, visuospatial span and mental motor inhibition.
|
Electroencephalographic signals registration during different levels of difficulty of three tasks requiring very distinct cognitive functions: the updating of verbal memory, visuospatial span and mental motor inhibition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of the variation in mental workload for different cognitive tasks.
Time Frame: Day 1
|
Concomitant evolution in healthy volunteers of the ElectroEncephaloGraphic (EEG) signals and of the subjective mental workload for different levels of difficulty of three tasks requiring very distinct cognitive functions: the updating of verbal memory, visuospatial span and mental motor inhibition.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Analysis of the influence of the quantity of EEG signals analyzed by our brain decoder on its accuracy
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent ROUALDES, Doctor, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC21_0590
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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