Healthy SubjectsNCT05185102
Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.
A study testing Cognitive tasks in people with Healthy Subjects, run by Nantes University Hospital at 1 site in France.
Trial summary
This study focuses on the identification of objective mental workload (through ElectroEncephaloGraphy) during tasks involving different cognitive functions. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Cognitive tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2022to 23 Jun 2022
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study focuses on the identification of objective mental workload (through ElectroEncephaloGraphy) during tasks involving different cognitive functions.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Cognitive tasks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tasksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive tasks | Experimental | 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. Receives: Other: Cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the variation in mental workload for different cognitive tasks.
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.
Measured: Day 1
Secondary outcomes (1)
Analysis of the influence of the quantity of EEG signals analyzed by our brain decoder on its accuracy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start4 May 2022
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent ROUALDES, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185102
- Sponsor's protocol ID
- RC21_0590
- Status last verified
- Sep 2022
- First submitted
- 23 Dec 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.
- ClinicalTrials.gov ID
- NCT05185102
- Acronym / sponsor ID
- RC21_0590
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 11 Jan 2022 (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.
This study focuses on the identification of objective mental workload (through ElectroEncephaloGraphy) during tasks involving different cognitive functions.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive tasks | Experimental | Other: Cognitive tasksElectroencephalographic 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Minors
- Adults under guardianship or curatorship
- Non-French speakers
- Sleep debt at the time of the experience
- Daltonism
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 |
|---|---|---|
| Cognitive tasksElectroencephalographic 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. | Other | Cognitive tasks |
Primary outcome
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.
1 secondary outcome
Analysis of the influence of the quantity of EEG signals analyzed by our brain decoder on its accuracy
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Vincent ROUALDES, Doctor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tasks in people with Healthy Subjects, run by Nantes University Hospital 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 27 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the variation in mental workload for different cognitive tasks. (time frame: Day 1). 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 27 Sep 2022; AzTrials last refreshed its copy on 31 Oct 2026.