Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population (3Electrods)

Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

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

Study Overview

• Status: Completed
• Conditions: Attitude to Computers
• Intervention / Treatment: Device: EEG Recording (Emotiv)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• France
  • Paris Area
    • Garches, Paris Area, France, 92380
      • Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extraction of P300 ERPs; Extract P300 ERPs with Emotiv EEG headset	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); Other Names: EEG recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Collaborators: National Research Agency, France
• Investigators: Study Director: Louis Mayaud, ENGINEER, Centre d'Investigation Clinique et Technologique 805

Publications and helpful links

Helpful Links

• CICIT 805 website

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Brain computer interface; EEG recording; Electrodes
• Other Study ID Numbers: 2011-A00102-39