Clinical trial NCT05113602: Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
Official title: Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volonteers
Lead sponsor: Urgotech
Sponsor class: INDUSTRY
Collaborators: name: ESPCI Paris
First posted: 2021-11-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 5 min recording
Secondary outcomes:
measure: 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
timeFrame: 5 min recording
measure: To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of SMR rhythm
timeFrame: 10 min recording
measure: To compare the measurement performed by URGOnight to the measurement performed by the Enobio 20 device of Individual Alpha frequencies
timeFrame: 10 min recording
Other outcomes:
measure: Optimize protocols to identify and distinguish individual Alpha and SMR peaks
timeFrame: 20 min recording
Locations:
city: Paris
country: France
facility: ESPCI
Study officials:
References: