An interventional study of GOLDSTANDARD and NEURONAUTE in Epilepsy, sponsored by BioSerenity. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by BioSerenity · Not applicable, Interventional, and Diagnostic
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
Browse Epilepsy studies →BioSerenity is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECORDING WITH EEG GOLD STANDARD
Device: GOLDSTANDARD
RECORDING WITH THE NEURONAUTE
Device: NEURONAUTE
RECORDING WITH EEG GOLDSTANDARD
RECORDING WITH NEURONAUTE
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
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 2 hours
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
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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