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

NCT03379272 | Withdrawn

• 1 other identifier: n°2016-A01754-47
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epilepsy

Keywords

Electroencephalography; Epilepsy; EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Neuronaute will be considered effective if it detects inter-critical epileptic abnormalities in at least one patient.

  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.

  2 hours

• The quality of the Neuronaute's ECG signal will be compared with the gold standard using an evaluation grid.

  1 year

Study Arms (2)

GOLD STANDARD

ACTIVE COMPARATOR

RECORDING WITH EEG GOLD STANDARD

Device: GOLDSTANDARD

NEURONAUTE

EXPERIMENTAL

RECORDING WITH THE NEURONAUTE

Device: NEURONAUTE

Interventions

GOLDSTANDARD DEVICE

RECORDING WITH EEG GOLDSTANDARD

GOLD STANDARD

NEURONAUTE DEVICE

RECORDING WITH NEURONAUTE

NEURONAUTE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• BioSerenity: lead
• Pitié-Salpêtrière Hospital: collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 20, 2017
• Study Start: December 20, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: November 11, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share