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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy
• Intervention / Treatment: Device: GOLDSTANDARD; Device: NEURONAUTE

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GOLD STANDARD; RECORDING WITH EEG GOLD STANDARD	Device: GOLDSTANDARD; RECORDING WITH EEG GOLDSTANDARD
Experimental: NEURONAUTE; RECORDING WITH THE NEURONAUTE	Device: NEURONAUTE; RECORDING WITH NEURONAUTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard.	The main evaluation criteria is the reproducibility based on the interpretation of electroencephalographic signals recorded by the Neuronaute compared to the gold standard. The system will be considered effective if there are no significant differences in the physiological parameters recorded by the two systems. A clinical expert will interpret the EEG(electroencephalography) signals and fill the EEG evaluation sheet. It includes items such as signals quality and presence of abnormal events	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Neuronaute will be considered effective if it detects inter-critical epileptic abnormalities in at least one patient.	A section of the evaluation sheet is designed for the secondary objectives.	1 year
The Neuronaute will be considered efficient if the installation time is at least as fast as the installation of the gold standard. The time will be measured from the beginning of the patient's preparation until the beginning of the recording.	The time needed to set up the clinical device and the device under test will be noted in the Case Report Form.	2 hours
The quality of the Neuronaute's ECG signal will be compared with the gold standard using an evaluation grid.	An evaluation grid led to compare the quality of th Neuronaute's ECG signal and Gold Standard' signal	1 year

Collaborators and Investigators

• Sponsor: BioSerenity
• Collaborators: Pitié-Salpêtrière Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2020
• Primary Completion (Anticipated): December 20, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Epilepsy; EEG; Electroencephalography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: n°2016-A01754-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No