NCT02843919

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

July 11, 2016

Last Update Submit

October 9, 2018

Conditions

Keywords

ElectrocardiographyElectroencephalographyNeural CorrelatesMental Workload

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Healthy volunteers

OTHER

Adults healthy volunteers

Other: Electroencephalography and Electrocardiography

Interventions

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (49)

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Study Officials

  • Laurent Verceuil, Doctor

    Grenoble Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 26, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations