Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
NCT ID: NCT03379272
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-12-20
2020-12-20
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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GOLD STANDARD
RECORDING WITH EEG GOLD STANDARD
GOLDSTANDARD
RECORDING WITH EEG GOLDSTANDARD
NEURONAUTE
RECORDING WITH THE NEURONAUTE
NEURONAUTE
RECORDING WITH NEURONAUTE
Interventions
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GOLDSTANDARD
RECORDING WITH EEG GOLDSTANDARD
NEURONAUTE
RECORDING WITH NEURONAUTE
Eligibility Criteria
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Inclusion Criteria
* Age (\> 18 years),
* Affiliated to the social security
* Informed consent.
Exclusion Criteria
* 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)
18 Years
85 Years
ALL
No
Sponsors
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Pitié-Salpêtrière Hospital
OTHER
BioSerenity
INDUSTRY
Responsible Party
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Other Identifiers
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n°2016-A01754-47
Identifier Type: -
Identifier Source: org_study_id