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Clinical Trials/NCT01518426
NCT01518426
Completed
Early Phase 1

Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

Centre d'Investigation Clinique et Technologique 8051 site in 1 country10 target enrollmentJune 2012

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Attitude to Computers
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
10
Locations
1
Primary Endpoint
Wilcoxon statistic (Area Under the Curve)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
July 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Wilcoxon statistic (Area Under the Curve)

Time Frame: 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.

Study Sites (1)

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