Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital (CONNECT)

BioSerenity

Status: Withdrawn

Conditions: Epilepsy

Treatments: Device: GOLDSTANDARD; Device: NEURONAUTE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03379272

n°2016-A01754-47

Details and patient eligibility

About

The proposed study is designed to evaluate the performance of the Neuronaute in comparison with the gold standard EEG in patients with a regular appointment at the hospital. The design of this study is guided by two overriding factors : (i) epileptics disorders suspected or either (ii) epileptics already diagnosed.

Volunteers will be asked to participate to this study. This study will enroll 35 outpatient subjects aged 18 to 85. Informed consent will be obtained from the patients, and assent from the subjects, prior to any form of assessment or intervention as part of the study.

Patients will be submitted to the studied device record Neuronaute following by the gold standard EEG.

A grid with all EEG activity recorded during the trial will be provided for evaluation after completion of the trial.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients, with a regular appointment to perform an EEG recording: (i) suspected of epileptic disorders or (ii) epilepsy already diagnosed.
• Age (> 18 years),
• Affiliated to the social security
• Informed consent.

Exclusion criteria

• No informed consent
• Age (< 18 years)
• No affiliation to the social security
• Unsuitable anthropometric parameters
• Pregnant women
• Recent brain surgery
• Wound or scores on the body and the scalp
• Ongoing participation in another clinical trial
• Allergy to any component from MD including : Silver, polyamide, silicone
• Sensory disorders making the patient insensitive to pain on the skin
• Behavioral disorders making the patient excessively agitated or aggressive;
• Motor or mental disorders preventing the patient from expressing his or her pain;
• Cardiorespiratory disorders likely to be aggravated by slight compression of the chest;
• The susceptibility to tension headaches (the compression exerted by the bonnet may in certain cases trigger a headache)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

GOLD STANDARD

Active Comparator group

Description:

RECORDING WITH EEG GOLD STANDARD

Treatment:

Device: GOLDSTANDARD

NEURONAUTE

Experimental group

Description:

RECORDING WITH THE NEURONAUTE

Treatment:

Device: NEURONAUTE