Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population

NCT ID: NCT01518426

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-07-31

Brief Summary

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

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.

Conditions

Attitude to Computers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Extraction of P300 ERPs

Extract P300 ERPs with Emotiv EEG headset

Group Type: EXPERIMENTAL

EEG Recording (Emotiv)

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

EEG recording

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Agency, France

OTHER

Sponsor Role: collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Mayaud, ENGINEER

Role: STUDY_DIRECTOR

Centre d'Investigation Clinique et Technologique 805

Locations

Raymond Poincaré Hospital

Garches, Paris Area, France

Countries

France

Other Identifiers

2011-A00102-39

Identifier Type: -

Identifier Source: org_study_id