Characterization of Independant Task Neural Correlates of Different Levels of Mental Workload (CARACOg)

The goal is to identify neuro-physiological signatures at several levels of mental workload during the realisation of tasks, performed by all the subjects.

In parallel, there will be a methodological work consisting to develop the classification algorithms, predictives of these levels of mental workload in real time, in purpose to implement a passive brain-machine interface in the best interest of operators that accomplish complex tasks.

Mesures of electro-physiological activity will be recorded in order to approve states of charge in addition to behavioral performances.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteer
• Intervention / Treatment: Other: Electroencephalography and Electrocardiography

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • UniversityHospitalGrenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent
• Medical examination made before search involvement
• Between 20 and 40 years
• Right-handed
• Minimum study level : Baccalauréat
• Membership of the French social security
• Normal vision and hearing (or corrected to normal)

Exclusion Criteria:

• Sujects included in a clinical or therapeutic trial in progress
• Vision or hearing essential disorder
• Neurological or neuropsychiatric pathology current or gone
• Drug treatment which could alter brain activity (antidepressants, benzodiazepine, lithium etc)
• Pregnant, parturient or breast feeding women
• All other category of protected people

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers; Adults healthy volunteers	Other: Electroencephalography and Electrocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (EEG)	With a EEG helmet. Classical Stemberg's task Stemberg's task with time pressure N-back task Mental arithmetic task 13 minutes MATB Multi-Attribute Task Battery : Divided attention task	10 minutes
Electrooculography (EOG)	Simultaneously to EEG : electrooculography (EOG) will be recorded With a EEG helmet. Classical Stemberg's task Stemberg's task with time pressure N-back task Mental arithmetic task 13 minutes MATB Multi-Attribute Task Battery : Divided attention task	10 minutes
Subjective and behavioral data	KSS scale to evaluate the patient's state of alertness Classical Stemberg's task Stemberg's task with time pressure N-back task Mental arithmetic task 13 minutes MATB Multi-Attribute Task Battery : Divided attention task	10 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Laurent Verceuil, Doctor, Grenoble Hospital University

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Electroencephalography; Electrocardiography; Neural Correlates; Mental Workload
• Other Study ID Numbers: 38RC14.009