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

Epilepsy Clinical Trial

— CONNECT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03379272
• Other study ID #: n°2016-A01754-47
• Status: Withdrawn
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: December 2020
• Source: BioSerenity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• GOLDSTANDARD
RECORDING WITH EEG GOLDSTANDARD
• NEURONAUTE
RECORDING WITH NEURONAUTE

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BioSerenity	Pitié-Salpêtrière Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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