Status:
WITHDRAWN
Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
Lead Sponsor:
BioSerenity
Collaborating Sponsors:
Pitié-Salpêtrière Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
18-85 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03379272
Start Date
December 20 2020
End Date
December 20 2020
Last Update
November 11 2021
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