Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population

Attitude to Computers Clinical Trial

— 3Electrods  

Official title:

Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518426
• Other study ID #: 2011-A00102-39
• Status: Completed
• Phase: Phase 0
• First received: December 22, 2011
• Last updated: May 5, 2014
• Start date: June 2012
• Est. completion date: July 2012

Study information

• Verified date: May 2014
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).

Description:

Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.

The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers male or female aging over 18

• Signed informed consent

• Passed the preliminary exam

• Registered in the national database for persons willing to participate in Biomedical research

Exclusion Criteria:

• Visual or hearing problems

• Cognitive problems

• Illiterate persons

• Persons under Guardianship or Trusteeship

• Having Epilepsy

• Pregnant women Not covered by the social security system

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Attitude to Computers

Intervention

Device:
• EEG Recording (Emotiv)
Record EEG during auditory oddball paradigms: with Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com) with 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm)

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital	Garches	Paris Area

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wilcoxon statistic (Area Under the Curve)	An Linear Discriminant Analysis (LDA) will be used to discriminate target and Algorithm performance (Wilcoxon statistic) for discrimination between occurrent and non-occurrent stimuli.; Signals will adequately be pre-processed: denoised and spatialy filtered (xDAWN). The Area Under the Receiver Operator Characteristic Curve (AUC) also called wilcoxon statistic will be used to identify the signals of best quality.	T0+2h (end of each technique)	No

External Links

•   CICIT 805 website