NCT01518426

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

December 22, 2011

Last Update Submit

May 5, 2014

Conditions

Attitude to Computers

Keywords

Brain computer interfaceEEG recordingElectrodes

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Extraction of P300 ERPs

EXPERIMENTAL

Extract P300 ERPs with Emotiv EEG headset

Device: EEG Recording (Emotiv)

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)

Also known as: EEG recording
Extraction of P300 ERPs

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Visual or hearing problems
  • Cognitive problems
  • Illiterate persons
  • Persons under Guardianship or Trusteeship
  • Having Epilepsy
  • Pregnant women Not covered by the social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincaré Hospital

Garches, Paris Area, 92380, France

Location

Study Officials

  • Louis Mayaud, ENGINEER

    Centre d'Investigation Clinique et Technologique 805

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 26, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

FR(1)