Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device (SIGMA)

The electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices.

The clinical development of therapies based on brain control has led to the emergence of numerous EEG devices that aim to allow mobile, autonomous, and easy use for users.

Data from the literature have proven the ability of neurofeedback (a form of biofeedback in which subjects respond to a display of their own brainwaves in order to improve their health or performance) to improve brain function in healthy or pathological subjects.

These therapeutic applications are offered in hospital settings with conventional systems and in the presence of a therapist.

The EEG measurement device URGOnight was developed with the aim of offering autonomous neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes (which do not send an electric current) and so-called dry electrodes, i.e. no gel or conductive paste is required.

Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by URGOnight and compare it with an electroencephalography device commonly used in clinical and research settings.

We will also evaluate the quality of the brain wave measurement usually retained in comparative studies of EEG systems.

Study Overview

• Status: Completed
• Conditions: Healthy Volonteers
• Intervention / Treatment: Device: URGOnight; Device: Enobio

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • ESPCI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years old
• Head circumference between 52 and 62 centimeters
• Affiliated or beneficiary of a social security system
• Protected persons in the sense of article L.1121-9 of the Public Health Code.

Exclusion Criteria:

• According to declarative :
• Use of medication or drugs with a possible effect on cognitive performance, such as benzodiazepines, antidepressants and antipsychotics
• Epilepsy
• The experimenter cannot get a good signal between the scalp and the electrodes at the beginning of the experiment (for example because of the type of hair or for any other technical reason).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simultaneous acquisition of EEG signals	Device: URGOnight; EEG dry electrodes portable device; Device: Enobio; EEG wet electrodes portable device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
effectiveness of the URGOnight device in detecting brain signals triggered by eye closure in the Alpha band (8-12 Hz) in comparison with the Enobio 20 device.	5 min recording

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Visual evoked potentials SSVEP at 4, 8, 10, 13, 15 and 20 hertz	5 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm	10 min recording
To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Individual Alpha frequencies	10 min recording

Other Outcome Measures

Outcome Measure	Time Frame
Optimize protocols to identify and distinguish individual Alpha and SMR peaks	20 min recording

Collaborators and Investigators

• Sponsor: Urgotech
• Collaborators: ESPCI Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SIGMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No