Epilepsy; SeizureECEMENCT05635396
Seizures Detection in Real Life Setting
A study testing Wearable, non invasive sensor for seizure detection in people with Epilepsy; Seizure and Focal Epilepsy, run by Reliev Technologies.
Trial summary
Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Epilepsy; Seizure, Focal Epilepsy
- What is being tested?
- Wearable, non invasive sensor for seizure detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2022to 15 Mar 2023
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 7 years old or more
- Patients with drug-resistant focal epilepsy
- Patients with high frequency seizures according to investigator's judgement
- Patients that can be followed 4 weeks after inclusion
- Informed consent form signed.
Who cannot join
- Generalised tonic-clonic seizures
- Frequent psychogenic non-epileptic seizures
- Pregnant or breastfeeding patients
- Patients displaying sensor contraindications
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Exploratory Study for Epileptic Seizures Detection Through Multimodal Analysis of Cardiorespiratory and Actimetry Parameters
Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities.
Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients.
Read more
Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising.
Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence.
This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).
- Conditions
- Epilepsy; Seizure, Focal Epilepsy
- Being tested
- Wearable, non invasive sensor for seizure detection
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable, non invasive sensor for seizure detectionDevice
The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. This sensor will be worn every day (on a 24 hours basis) excepted during weekends for up to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Wearable, non invasive sensor for vital signs recording. | Experimental | All included patients will be provided with a wearable, non invasive sensor for vital signs recording. Receives: Device: Wearable, non invasive sensor for seizure detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of true positive seizures.
The number of true positive seizures will be measured, ie. seizures detected through the sensor and reported in a seizures diary completed in real time by care giver.
Measured: From baseline up to 4 weeks.
Number of false positive seizures.
The number of false positive seizures will be measured, ie. seizures detected through the sensor but not reported in the seizures diary completed in real time by care giver.
Measured: From baseline up to 4 weeks.
Number of false negative seizures.
The number of false negative seizures will be measured, ie. seizures not detected through the sensor but reported in the seizures diary completed in real time by care giver.
Measured: From baseline up to 4 weeks.
Secondary outcomes (10)
Changes in Number of true positive, true negative and false negative seizures throughout the study duration.
Data from sensor will be analysed and compared to seizures diary.
Measured: From baseline up to 4 weeks.
Changes in number of true positive, true negative and false negative seizures depending on patients' characteristics.
Number of true positive, true negative and false negative seizures will be analysed and compared between patients based on patients' clinical characteristics.
Measured: From baseline up to 4 weeks.
Sensor tolerability from patients' perspective.
The French Version of the System Usability Scale (F-SUS) will be used. It is a self-questionnaire including 10 questions, ranging from 0 "I do not agree at all" up to 10 "I completely agree".
Measured: At 4 weeks after baseline.
Sensor tolerability from care givers' perspective.
A self-questionnaire including 5 questions will be used, ranging from 0 "I do not agree at all" up to 10 "I completely agree".
Measured: At 4 weeks after baseline.
Electrocardiogram signal quality in real life setting.
Electrocardiogram signal quality will be compared between data obtained from sensor (real life setting) and data obtained from video-EEG monitoring (hospital setting).
Measured: From baseline up to 4 weeks.
ECG data impact (ECG characteristics) on seizures detection.
Contribution from ECG data will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.
Measured: From baseline up to 4 weeks.
Heart rate impact on seizures detection.
Contribution of data from heart rate will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.
Measured: From baseline up to 4 weeks.
Respiration rate impact on seizures detection.
Contribution of data from respiration rate will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.
Measured: From baseline up to 4 weeks.
Body orientation impact on seizures detection.
Contribution from body orientation data will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.
Measured: From baseline up to 4 weeks.
Activity impact on seizures detection.
Contribution of activity data will be analysed as stand-alone parameter and as associated parameter in multimodal monitoring.
Measured: From baseline up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy; SeizureStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reliev Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvia NAPURI, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635396
- Sponsor's protocol ID
- ECEME
- Other IDs
- 2022-A01565-38
- Acronym
- ECEME
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Exploratory Study for Epileptic Seizures Detection Through Multimodal Analysis of Cardiorespiratory and Actimetry Parameters
- ClinicalTrials.gov ID
- NCT05635396
- Acronym / sponsor ID
- ECEME / ECEME
- Conditions
- Epilepsy; Seizure, Focal Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Reliev TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 2 Dec 2022 (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.
Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities.
Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients.
Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising.
Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence.
This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable, non invasive sensor for vital signs recording. | Experimental | Device: Wearable, non invasive sensor for seizure detectionAll included patients will be provided with a wearable, non invasive sensor for vital signs recording. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 7 years old or more
- Patients with drug-resistant focal epilepsy
- Patients with high frequency seizures according to investigator's judgement
- Patients that can be followed 4 weeks after inclusion
- Informed consent form signed.
Key exclusion criteria (4 listed)
- Generalised tonic-clonic seizures
- Frequent psychogenic non-epileptic seizures
- Pregnant or breastfeeding patients
- Patients displaying sensor contraindications
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 |
|---|---|---|
| Wearable, non invasive sensor for seizure detectionThe device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. This sensor will be worn every day (on a 24 hours basis) excepted during weekends for up to 4 weeks. | Device | Wearable, non invasive sensor for vital signs recording. |
Primary outcome
Number of true positive seizures.
Time frame: From baseline up to 4 weeks.
The number of true positive seizures will be measured, ie. seizures detected through the sensor and reported in a seizures diary completed in real time by care giver.
Number of false positive seizures.
Time frame: From baseline up to 4 weeks.
The number of false positive seizures will be measured, ie. seizures detected through the sensor but not reported in the seizures diary completed in real time by care giver.
Number of false negative seizures.
Time frame: From baseline up to 4 weeks.
The number of false negative seizures will be measured, ie. seizures not detected through the sensor but reported in the seizures diary completed in real time by care giver.
10 secondary outcomes
Changes in Number of true positive, true negative and false negative seizures throughout the study duration.
Time frame: From baseline up to 4 weeks.
Changes in number of true positive, true negative and false negative seizures depending on patients' characteristics.
Time frame: From baseline up to 4 weeks.
Sensor tolerability from patients' perspective.
Time frame: At 4 weeks after baseline.
Sensor tolerability from care givers' perspective.
Time frame: At 4 weeks after baseline.
Electrocardiogram signal quality in real life setting.
Time frame: From baseline up to 4 weeks.
ECG data impact (ECG characteristics) on seizures detection.
Time frame: From baseline up to 4 weeks.
Heart rate impact on seizures detection.
Time frame: From baseline up to 4 weeks.
Respiration rate impact on seizures detection.
Time frame: From baseline up to 4 weeks.
Body orientation impact on seizures detection.
Time frame: From baseline up to 4 weeks.
Activity impact on seizures detection.
Time frame: From baseline up to 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
Silvia NAPURI, MD principal investigator
Rennes University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Wearable, non invasive sensor for seizure detection in people with Epilepsy; Seizure and Focal Epilepsy, run by Reliev Technologies.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent RIBIERE ((0)6 52 27 52 02 ext. +33, l.ribiere@reliev.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of true positive seizures. (time frame: From baseline up to 4 weeks.). The study lists 3 primary outcomes in all. 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 2 Dec 2022.