Clinical trial NCT03379272: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
Official title: CONNECT: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Keywords: Electroencephalography
Epilepsy
EEG
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
Collaborators: name: Pitié-Salpêtrière Hospital
First posted: 2017-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard.
timeFrame: 1 year
Secondary outcomes:
measure: The Neuronaute will be considered effective if it detects inter-critical epileptic abnormalities in at least one patient.
timeFrame: 1 year
measure: 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.
timeFrame: 2 hours
measure: The quality of the Neuronaute's ECG signal will be compared with the gold standard using an evaluation grid.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: