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

NCT05113602 | Completed

• 1 other identifier: SIGMA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volonteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (1)

• Optimize protocols to identify and distinguish individual Alpha and SMR peaks

  20 min recording

Study Arms (1)

Simultaneous acquisition of EEG signals

EXPERIMENTAL

Device: URGOnight; Device: Enobio

Interventions

URGOnight DEVICE

EEG dry electrodes portable device

Simultaneous acquisition of EEG signals

Enobio DEVICE

EEG wet electrodes portable device

Simultaneous acquisition of EEG signals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Urgotech: lead
• ESPCI Paris: collaborator

Study Sites (1)

ESPCI

Paris, 75005, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: January 26, 2021
• Primary Completion: January 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-10

Locations

FR (1)