Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population

Early Phase 1CompletedNCT01518426

Centre d'Investigation Clinique et Technologique 80510 enrolled

Overview

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

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Attitude to Computers

Interventions

EEG Recording (Emotiv)DEVICE

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Raymond Poincaré Hospital

Garches, Paris Area, France

Outcomes

Primary Outcomes

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.

Time frame: T0+2h (end of each technique)

Data from ClinicalTrials.gov

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