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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02843919
Other study ID # 38RC14.009
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date December 2017

Study information

Verified date October 2018
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Electroencephalography and Electrocardiography


Locations

Country Name City State
France UniversityHospitalGrenoble La Tronche

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (49)

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* Note: There are 49 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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