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

U

URGO Group

Status

Completed

Conditions

Healthy Volonteers

Treatments

Device: URGOnight
Device: Enobio

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Simultaneous acquisition of EEG signals
Experimental group
Treatment:
Device: URGOnight
Device: Enobio

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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