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Completed

NCT Number: NCT01518426

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).

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Key information

Conditions

Attitude to Computers

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Raymond Poincaré Hospital

Garches, Paris Area, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: EEG recording

Primary outcomes

  1. Wilcoxon statistic (Area Under the Curve)

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

    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.

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • National Research Agency, France

Registry information

Official study title

Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

Acronym: 3Electrods

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2012
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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