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

Primary Purpose

Epilepsy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GOLDSTANDARD
NEURONAUTE
Sponsored by
BioSerenity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring Electroencephalography, Epilepsy, EEG

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    GOLD STANDARD

    NEURONAUTE

    Arm Description

    RECORDING WITH EEG GOLD STANDARD

    RECORDING WITH THE NEURONAUTE

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.
    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

    Full Information

    First Posted
    December 7, 2016
    Last Updated
    November 5, 2021
    Sponsor
    BioSerenity
    Collaborators
    Pitié-Salpêtrière Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03379272
    Brief Title
    Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
    Acronym
    CONNECT
    Official Title
    CONNECT: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Device evolves.
    Study Start Date
    December 20, 2020 (Anticipated)
    Primary Completion Date
    December 20, 2020 (Anticipated)
    Study Completion Date
    December 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BioSerenity
    Collaborators
    Pitié-Salpêtrière Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    Electroencephalography, Epilepsy, EEG

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GOLD STANDARD
    Arm Type
    Active Comparator
    Arm Description
    RECORDING WITH EEG GOLD STANDARD
    Arm Title
    NEURONAUTE
    Arm Type
    Experimental
    Arm Description
    RECORDING WITH THE NEURONAUTE
    Intervention Type
    Device
    Intervention Name(s)
    GOLDSTANDARD
    Intervention Description
    RECORDING WITH EEG GOLDSTANDARD
    Intervention Type
    Device
    Intervention Name(s)
    NEURONAUTE
    Intervention Description
    RECORDING WITH NEURONAUTE
    Primary Outcome Measure Information:
    Title
    Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard.
    Description
    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
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    The Neuronaute will be considered effective if it detects inter-critical epileptic abnormalities in at least one patient.
    Description
    A section of the evaluation sheet is designed for the secondary objectives.
    Time Frame
    1 year
    Title
    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.
    Description
    The time needed to set up the clinical device and the device under test will be noted in the Case Report Form.
    Time Frame
    2 hours
    Title
    The quality of the Neuronaute's ECG signal will be compared with the gold standard using an evaluation grid.
    Description
    An evaluation grid led to compare the quality of th Neuronaute's ECG signal and Gold Standard' signal
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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