EpilepsyCONNECTNCT03379272
Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
A study testing GOLDSTANDARD and NEURONAUTE in people with Epilepsy, run by BioSerenity.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- GOLDSTANDARD and NEURONAUTE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2020to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No informed consent
- Age (< 18 years)
- No affiliation to the social security
- Unsuitable anthropometric parameters
- Pregnant women
- Recent brain surgery
Show all 14Show fewer
- 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)
About this study
Official title: CONNECT: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
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.
Read more
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.
- Conditions
- Epilepsy
- Being tested
- GOLDSTANDARD, NEURONAUTE
- Keywords
- Electroencephalography, Epilepsy, EEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOLDSTANDARDDevice
RECORDING WITH EEG GOLDSTANDARD
NEURONAUTEDevice
RECORDING WITH NEURONAUTE
| Study group | Role | What they receive |
|---|---|---|
| GOLD STANDARD | Active comparator | RECORDING WITH EEG GOLD STANDARD Receives: Device: GOLDSTANDARD |
| NEURONAUTE | Experimental | RECORDING WITH THE NEURONAUTE Receives: Device: NEURONAUTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start20 Dec 2020 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Why it stopped: Device evolves.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379272
- Sponsor's protocol ID
- n°2016-A01754-47
- Acronym
- CONNECT
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2016
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONNECT: Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital
- ClinicalTrials.gov ID
- NCT03379272
- Acronym / sponsor ID
- CONNECT / n°2016-A01754-47
- Conditions
- Epilepsy
- Keywords
- Electroencephalography, Epilepsy, EEG
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device evolves.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- 20 Dec 2020 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOLD STANDARD | Active comparator | Device: GOLDSTANDARDRECORDING WITH EEG GOLD STANDARD |
| NEURONAUTE | Experimental | Device: NEURONAUTERECORDING WITH THE NEURONAUTE |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- No informed consent
- Age (< 18 years)
- No affiliation to the social security
- Unsuitable anthropometric parameters
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOLDSTANDARDRECORDING WITH EEG GOLDSTANDARD | Device | GOLD STANDARD |
| NEURONAUTERECORDING WITH NEURONAUTE | Device | NEURONAUTE |
Primary outcome
Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard.
Time frame: 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
3 secondary outcomes
The Neuronaute will be considered effective if it detects inter-critical epileptic abnormalities in at least one patient.
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.
Time frame: 2 hours
The quality of the Neuronaute's ECG signal will be compared with the gold standard using an evaluation grid.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GOLDSTANDARD and NEURONAUTE in people with Epilepsy, run by BioSerenity.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of electroencephalographic signals interpretation recorded by the Neuronaute compared to the gold standard. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.