CONNECT: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard. [1 year]
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. [1 year]
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. [2 hours]
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. [1 year]
An evaluation grid led to compare the quality of th Neuronaute's ECG signal and Gold Standard' signal
Eligibility Criteria
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- BioSerenity
- Pitié-Salpêtrière Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- n°2016-A01754-47