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

Healthy Volonteers Clinical Trial

— SIGMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113602
• Other study ID #: SIGMA
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Urgotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volonteers

Intervention

Device:
• URGOnight
EEG dry electrodes portable device
• Enobio
EEG wet electrodes portable device

Locations

Country	Name	City	State
France	ESPCI	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Urgotech	ESPCI Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optimize protocols to identify and distinguish individual Alpha and SMR peaks		20 min recording
Primary	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	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
Secondary	To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm		10 min recording
Secondary	To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Individual Alpha frequencies		10 min recording