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

This study has been completed.
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01518426
First received: December 22, 2011
Last updated: May 5, 2014
Last verified: May 2014

December 22, 2011
May 5, 2014
June 2012
July 2012   (final data collection date for primary outcome measure)
Wilcoxon statistic (Area Under the Curve) [ Time Frame: T0+2h (end of each technique) ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01518426 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population
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).

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Attitude to Computers
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 Name: EEG recording
Experimental: Extraction of P300 ERPs
Extract P300 ERPs with Emotiv EEG headset
Intervention: Device: EEG Recording (Emotiv)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01518426
2011-A00102-39
Yes
Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
National Research Agency, France
Study Director: Louis Mayaud, ENGINEER Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP