Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population

Early Phase 1

Completed

• Conditions: Attitude to Computers

• Registration Number: NCT01518426
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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.

Study Timeline

• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2012-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Wilcoxon statistic (Area Under the Curve)	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.

Trial Locations

Locations (1)

Raymond Poincaré Hospital; 🇫🇷 Garches, Paris Area, France