EpilepsyNCT04642105
Sensor-Dot and Plug 'n Patch Study in Epilepsy
A study testing Sensor-Dot and Plug 'n Patch system in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The investigators plan to determine whether it is possible to use a small, unobtrusive wearable device (the Sensor Dot with Plug 'n Patch system) to follow-up epilepsy in the home environment through measurement of different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Sensor-Dot and Plug 'n Patch system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 6 May 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are 18 years of age or older, who signed an informed consent form, and teenagers over 16 years of age who assent, with their parents signing an informed consent form, and:
- Epilepsy syndrome: idiopathic generalized epilepsy (n=15), patients at increased risk for SUDEP, i.e. have more than 1 nocturnal tonic clonic seizures (TCS) per month (n=15), refractory focal epilepsy with a presurgical evaluation at UZ Leuven (n=30)
- Minimum one seizure per month
- Patient is able and motivated to handle the Sensor-Dot and Plug 'n Patch system independently, to fill out the Helpilepsy app on a daily basis and to wear the Sensor-Dot and Plug 'n Patch system for a full year 24/24-7/7; fallback option for patients for whom wearing the device during the day is too obtrusive: measurement only during the evening and nighttime.
Who cannot join
- Inability to provide written informed consent or assent.
- Known allergy to electrodes and patches.
- Implanted device, such as a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Profiling of People With Epilepsy to Determine Which Signals Are Clinically Useful for Long-term Home Monitoring
The investigators plan to determine whether it is possible to use a small, unobtrusive wearable device (the Sensor Dot with Plug 'n Patch system) to follow-up epilepsy in the home environment through measurement of different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for prolonged periods in patients with epilepsy. If this is possible, the investigators will study the chronobiology of epilepsy.
Read the detailed description
In this study, the investigators will make use of a small, discrete and unobtrusive wearable, the Sensor-Dot (https://www.byteflies.com/) and newly developed electrode patches (Plug 'n Patch system). The aim is multimodal profiling of people with epilepsy to determine which signals are clinically useful for long-term home monitoring. Biosignals that will be registered include EEG, EMG, and ECG, respiration, oxygen saturation, skin temperature and motion.
The first part of the study is hospital-based and will last 5 days. The investigators will compare the biosignals of the Sensor Dot and the Plug 'n Patch system with those measured with hospital equipment. Participants are 15 patients with refractory focal epilepsy who will be admitted to the hospital for long-term videoEEG registration of epileptic seizures as part of a presurgical evaluation.
The second part of the study is home-based and will last for a maximum of 1 year. Sixty participants will be selected with refractory idiopathic generalized epilepsy (n=15), refractory focal epilepsy (n=30) and frequent nocturnal tonic-clonic seizures (n=15). The aim is to determine and improve usability of the Sensor Dot and Plug 'n Patch system upon long-term use in the home environment. The investigators will determine the number of patients with side effects and adverse events of the Sensor Dot and Plug 'n Patch system, e.g. contact allergic eczema. The investigators will determine the total time that participants wear the Sensor Dot and Plug 'n Patch system, and the reason why participants do not wear it.
The investigators further aim to determine whether epileptic seizures occur in cycles, and will study interactions between epilepsy and sleep. The investigators will also study whether body temperature occurs in recurring cycles and is related with the occurrence of epileptic seizures. The investigators will study changes in EEG, respiration, heart rate, skin temperature and oxygen saturation during tonic-clonic seizures. The investigators will determine whether it is possible that the Sensor-Dot and Plug 'n Patch system can be used as a seizure forecaster.
- Conditions
- Epilepsy
- Being tested
- Sensor-Dot and Plug 'n Patch system
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-Dot and Plug 'n Patch systemDevice
We will use a small, unobtrusive wearable (Sensor-Dot) to measure different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for up to one year using newly developed skin adhesives and patches (Plug 'n Patch system)
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based study | Experimental | The investigators will select 15 patients with refractory focal epilepsy who are admitted to the videoEEG room for longterm videoEEG recording as part of a presurgical evaluation. The Sensor-Dot and Plug 'n Patch recordings will be compared with the gold-standard videoEEG recordings. Receives: Device: Sensor-Dot and Plug 'n Patch system |
| Home-based study | Experimental | The investigators will select 30 patients with refractory focal epilepsy, 15 patients with refractory idiopathic generalized epilepsy and 15 patients with frequent tonic-clonic seizures, i.e. a group at increased risk for sudden unexpected death in epilepsy (SUDEP). Receives: Device: Sensor-Dot and Plug 'n Patch system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epileptic seizures
In the hospital-based study, the investigators will compare the number epileptic seizures measured with the Sensor-Dot and Plug 'n Patch system in comparison with the hospital-based equipment.
Measured: 5 days
Heart rate
In the hospital-based study, the investigators will compare the heartrate of participants measured with the Sensor-Dot and Plug 'n Patch system in comparison with hospital-based equipment.
Measured: 5 days
Oxygen saturation
In the hospital-based study, the investigators will compare oxygen saturation of participants measured with a finger pulse oximetry versus the Sensor-Dot and Plug 'n Patch system.
Measured: 5 days
Respiration
In the hospital-based study, the investigators will compare the respiration rate of participants measured with a chest belt during videoEEG registration versus the Sensor-Dot and Plug 'n Patch system.
Measured: 5 days
Skin temperature
In the hospital-based study, the investigators will compare the skin temperature of participants using axillary measurement with a negative temperature coefficient thermistor versus the Sensor-Dot and Plug 'n Patch system, which is based on infrared thermometry.
Measured: 5 days
Number of participants with adverse events and side effects
In the home-based study, the investigators will determine the number of patients with side effects and adverse events of the Sensor Dot and Plug 'n Patch system, e.g. contact allergic eczema
Measured: 1 year
Total time that participants wear the Sensor-Dot and Plug 'n Patch system
In the home-based study, the investigators will determine the total time that participants wear the Sensor Dot and Plug 'n Patch system, and the reason why participants do not wear it
Measured: 1 year
Secondary outcomes (7)
Cycles in epileptic seizure
To study whether epileptic seizures occur in recurring cycles or patterns
Measured: 1 year
Cycles in interictal epileptic discharges
To study whether interictal epileptic discharges occur in recurring cycles or patterns
Measured: 1 year
Cycles in sleep patterns
To study whether sleep occurs in recurring cycles or patterns
Measured: 1 year
Cycles in body temperature
To study whether body temperature occurs in recurring cycles or patterns
Measured: 1 year
Seizure forecasting
To study whether cycles in epileptic seizures, interictal epileptic discharges, sleep and skin temperature allow to define a pro-ictal state during which the occurrence of epileptic seizures is more likely, i.e. seizure forecasting
Measured: 1 year
Physiological changes during tonic-clonic seizures
To study changes in EEG, respiration, heart rate, skin temperature and oxygen saturation during tonic-clonic seizures
Measured: 1 year
Catamenial epilepsy
To determine if changes in IEDs, skin temperature, sleep cycles can define seizure recurrence in women with catamenial epilepsy
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 posted24 Nov 2020
- Study start1 Mar 2021
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Hospital-based study: 15 patients will be selected in this study which will last 5 days. Home-based study: 60 patients will be selected in this study which will last a maximum of 1 year.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Byteflies
- Responsible party
- Sponsor
- Investigators
- Wim Van Paesschen, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642105
- Sponsor's protocol ID
- S64726
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the individual biosignals (EEG, EMG, ECG, movement, skin temperature, respiration), de-identified demographics and epilepsy-related data two years after the finish of the study upon request to researchers who provide a methodologically sound proposal.
Publications
Paesschen WV. The future of seizure detection. Lancet Neurol. 2018 Mar;17(3):200-202. doi: 10.1016/S1474-4422(18)30034-6. No abstract available.
PubMed 29452676Verdru J, Van Paesschen W. Wearable seizure detection devices in refractory epilepsy. Acta Neurol Belg. 2020 Dec;120(6):1271-1281. doi: 10.1007/s13760-020-01417-z. Epub 2020 Jul 6.
PubMed 32632710Mikkelsen KB, Ebajemito JK, Bonmati-Carrion MA, Santhi N, Revell VL, Atzori G, Della Monica C, Debener S, Dijk DJ, Sterr A, de Vos M. Machine-learning-derived sleep-wake staging from around-the-ear electroencephalogram outperforms manual scoring and actigraphy. J Sleep Res. 2019 Apr;28(2):e12786. doi: 10.1111/jsr.12786. Epub 2018 Nov 13.
PubMed 30421469Gu Y, Cleeren E, Dan J, Claes K, Van Paesschen W, Van Huffel S, Hunyadi B. Comparison between Scalp EEG and Behind-the-Ear EEG for Development of a Wearable Seizure Detection System for Patients with Focal Epilepsy. Sensors (Basel). 2017 Dec 23;18(1):29. doi: 10.3390/s18010029.
PubMed 29295522De Cooman T, Vandecasteele K, Varon C, Hunyadi B, Cleeren E, Van Paesschen W, Van Huffel S. Personalizing Heart Rate-Based Seizure Detection Using Supervised SVM Transfer Learning. Front Neurol. 2020 Feb 26;11:145. doi: 10.3389/fneur.2020.00145. eCollection 2020.
PubMed 32161573Vandecasteele K, De Cooman T, Dan J, Cleeren E, Van Huffel S, Hunyadi B, Van Paesschen W. Visual seizure annotation and automated seizure detection using behind-the-ear electroencephalographic channels. Epilepsia. 2020 Apr;61(4):766-775. doi: 10.1111/epi.16470. Epub 2020 Mar 11.
PubMed 32160324
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Profiling of People With Epilepsy to Determine Which Signals Are Clinically Useful for Long-term Home Monitoring
- ClinicalTrials.gov ID
- NCT04642105
- Acronym / sponsor ID
- S64726
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Byteflies
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 24 Nov 2020 (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 investigators plan to determine whether it is possible to use a small, unobtrusive wearable device (the Sensor Dot with Plug 'n Patch system) to follow-up epilepsy in the home environment through measurement of different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for prolonged periods in patients with epilepsy. If this is possible, the investigators will study the chronobiology of epilepsy.
Detailed description
In this study, the investigators will make use of a small, discrete and unobtrusive wearable, the Sensor-Dot (https://www.byteflies.com/) and newly developed electrode patches (Plug 'n Patch system). The aim is multimodal profiling of people with epilepsy to determine which signals are clinically useful for long-term home monitoring. Biosignals that will be registered include EEG, EMG, and ECG, respiration, oxygen saturation, skin temperature and motion.
The first part of the study is hospital-based and will last 5 days. The investigators will compare the biosignals of the Sensor Dot and the Plug 'n Patch system with those measured with hospital equipment. Participants are 15 patients with refractory focal epilepsy who will be admitted to the hospital for long-term videoEEG registration of epileptic seizures as part of a presurgical evaluation.
The second part of the study is home-based and will last for a maximum of 1 year. Sixty participants will be selected with refractory idiopathic generalized epilepsy (n=15), refractory focal epilepsy (n=30) and frequent nocturnal tonic-clonic seizures (n=15). The aim is to determine and improve usability of the Sensor Dot and Plug 'n Patch system upon long-term use in the home environment. The investigators will determine the number of patients with side effects and adverse events of the Sensor Dot and Plug 'n Patch system, e.g. contact allergic eczema. The investigators will determine the total time that participants wear the Sensor Dot and Plug 'n Patch system, and the reason why participants do not wear it.
The investigators further aim to determine whether epileptic seizures occur in cycles, and will study interactions between epilepsy and sleep. The investigators will also study whether body temperature occurs in recurring cycles and is related with the occurrence of epileptic seizures. The investigators will study changes in EEG, respiration, heart rate, skin temperature and oxygen saturation during tonic-clonic seizures. The investigators will determine whether it is possible that the Sensor-Dot and Plug 'n Patch system can be used as a seizure forecaster.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hospital-based study: 15 patients will be selected in this study which will last 5 days. Home-based study: 60 patients will be selected in this study which will last a maximum of 1 year.
| Arm | Type | Receives |
|---|---|---|
| Hospital-based study | Experimental | Device: Sensor-Dot and Plug 'n Patch systemThe investigators will select 15 patients with refractory focal epilepsy who are admitted to the videoEEG room for longterm videoEEG recording as part of a presurgical evaluation. The Sensor-Dot and Plug 'n Patch recordings will be compared with the gold-standard videoEEG recordings. |
| Home-based study | Experimental | Device: Sensor-Dot and Plug 'n Patch systemThe investigators will select 30 patients with refractory focal epilepsy, 15 patients with refractory idiopathic generalized epilepsy and 15 patients with frequent tonic-clonic seizures, i.e. a group at increased risk for sudden unexpected death in epilepsy (SUDEP). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 18 years of age or older, who signed an informed consent form, and teenagers over 16 years of age who assent, with their parents signing an informed consent form, and:
- Epilepsy syndrome: idiopathic generalized epilepsy (n=15), patients at increased risk for SUDEP, i.e. have more than 1 nocturnal tonic clonic seizures (TCS) per month (n=15), refractory focal epilepsy with a presurgical evaluation at UZ Leuven (n=30)
- Minimum one seizure per month
- Patient is able and motivated to handle the Sensor-Dot and Plug 'n Patch system independently, to fill out the Helpilepsy app on a daily basis and to wear the Sensor-Dot and Plug 'n Patch system for a full year 24/24-7/7; fallback option for patients for whom wearing the device during the day is too obtrusive: measurement only during the evening and nighttime.
Key exclusion criteria (3 listed)
- Inability to provide written informed consent or assent.
- Known allergy to electrodes and patches.
- Implanted device, such as a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device.
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 |
|---|---|---|
| Sensor-Dot and Plug 'n Patch systemWe will use a small, unobtrusive wearable (Sensor-Dot) to measure different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for up to one year using newly developed skin adhesives and patches (Plug 'n Patch system) | Device | Home-based study, Hospital-based study |
Primary outcome
Epileptic seizures
Time frame: 5 days
In the hospital-based study, the investigators will compare the number epileptic seizures measured with the Sensor-Dot and Plug 'n Patch system in comparison with the hospital-based equipment.
Heart rate
Time frame: 5 days
In the hospital-based study, the investigators will compare the heartrate of participants measured with the Sensor-Dot and Plug 'n Patch system in comparison with hospital-based equipment.
Oxygen saturation
Time frame: 5 days
In the hospital-based study, the investigators will compare oxygen saturation of participants measured with a finger pulse oximetry versus the Sensor-Dot and Plug 'n Patch system.
Respiration
Time frame: 5 days
In the hospital-based study, the investigators will compare the respiration rate of participants measured with a chest belt during videoEEG registration versus the Sensor-Dot and Plug 'n Patch system.
Skin temperature
Time frame: 5 days
In the hospital-based study, the investigators will compare the skin temperature of participants using axillary measurement with a negative temperature coefficient thermistor versus the Sensor-Dot and Plug 'n Patch system, which is based on infrared thermometry.
Number of participants with adverse events and side effects
Time frame: 1 year
In the home-based study, the investigators will determine the number of patients with side effects and adverse events of the Sensor Dot and Plug 'n Patch system, e.g. contact allergic eczema
Total time that participants wear the Sensor-Dot and Plug 'n Patch system
Time frame: 1 year
In the home-based study, the investigators will determine the total time that participants wear the Sensor Dot and Plug 'n Patch system, and the reason why participants do not wear it
7 secondary outcomes
Cycles in epileptic seizure
Time frame: 1 year
Cycles in interictal epileptic discharges
Time frame: 1 year
Cycles in sleep patterns
Time frame: 1 year
Cycles in body temperature
Time frame: 1 year
Seizure forecasting
Time frame: 1 year
Physiological changes during tonic-clonic seizures
Time frame: 1 year
Catamenial epilepsy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 29452676Paesschen WV. The future of seizure detection. Lancet Neurol. 2018 Mar;17(3):200-202. doi: 10.1016/S1474-4422(18)30034-6. No abstract available.
- Background: PubMed 32632710Verdru J, Van Paesschen W. Wearable seizure detection devices in refractory epilepsy. Acta Neurol Belg. 2020 Dec;120(6):1271-1281. doi: 10.1007/s13760-020-01417-z. Epub 2020 Jul 6.
- Background: PubMed 30421469Mikkelsen KB, Ebajemito JK, Bonmati-Carrion MA, Santhi N, Revell VL, Atzori G, Della Monica C, Debener S, Dijk DJ, Sterr A, de Vos M. Machine-learning-derived sleep-wake staging from around-the-ear electroencephalogram outperforms manual scoring and actigraphy. J Sleep Res. 2019 Apr;28(2):e12786. doi: 10.1111/jsr.12786. Epub 2018 Nov 13.
- Background: PubMed 29295522Gu Y, Cleeren E, Dan J, Claes K, Van Paesschen W, Van Huffel S, Hunyadi B. Comparison between Scalp EEG and Behind-the-Ear EEG for Development of a Wearable Seizure Detection System for Patients with Focal Epilepsy. Sensors (Basel). 2017 Dec 23;18(1):29. doi: 10.3390/s18010029.
- Background: PubMed 32161573De Cooman T, Vandecasteele K, Varon C, Hunyadi B, Cleeren E, Van Paesschen W, Van Huffel S. Personalizing Heart Rate-Based Seizure Detection Using Supervised SVM Transfer Learning. Front Neurol. 2020 Feb 26;11:145. doi: 10.3389/fneur.2020.00145. eCollection 2020.
- Background: PubMed 32160324Vandecasteele K, De Cooman T, Dan J, Cleeren E, Van Huffel S, Hunyadi B, Van Paesschen W. Visual seizure annotation and automated seizure detection using behind-the-ear electroencephalographic channels. Epilepsia. 2020 Apr;61(4):766-775. doi: 10.1111/epi.16470. Epub 2020 Mar 11.
- Individual participant dataSharing planned: Yes. We plan to share the individual biosignals (EEG, EMG, ECG, movement, skin temperature, respiration), de-identified demographics and epilepsy-related data two years after the finish of the study upon request to researchers who provide a methodologically sound proposal.
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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.
Wim Van Paesschen, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-Dot and Plug 'n Patch system in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epileptic seizures (time frame: 5 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642105, which also lists 6 linked publications.
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 8 May 2024.