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
  Purpose

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


Condition Intervention Phase
Attitude to Computers
Device: EEG Recording (Emotiv)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • 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.



Enrollment: 10
Study Start Date: June 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EEG recording

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518426

Locations
France
Raymond Poincaré Hospital
Garches, Paris Area, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
National Research Agency, France
Investigators
Study Director: Louis Mayaud, ENGINEER Centre d'Investigation Clinique et Technologique 805
  More Information

Additional Information:
No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01518426     History of Changes
Other Study ID Numbers: 2011-A00102-39
Study First Received: December 22, 2011
Last Updated: May 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Brain computer interface
EEG recording
Electrodes

ClinicalTrials.gov processed this record on July 26, 2014