Epilepsy; SeizureForesightNCT06275685
Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking
A study testing SeizureWise algorithm and Multi-day Visualizations in people with Epilepsy; Seizure, run by Empatica, Inc. at 1 site in United States.
Trial summary
The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy. The main questions it aims to answer are: can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy; Seizure
- What is being tested?
- SeizureWise algorithm and Multi-day Visualizations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to Jun 2026
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must be diagnosed with or be at risk of epilepsy
- Subjects or their parents or guardians must understand and consent to be in the study;
- Subjects or their parents or guardians must be able to read and communicate in English;
- Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;
- Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.
Who cannot join
- Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;
- Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);
- Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or
- Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Empatica
Boston, Massachusetts, 02111
Empatica, 855-830-3531, support@empatica.com
About this study
Official title: Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.
The main questions it aims to answer are:
- can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
- does this tool improve the lives of people with epilepsy?
Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.
Read the detailed description
The primary goal of the study is to demonstrate the accuracy of SeizureWise in predicting the timing of future convulsive seizures using data collected by the wearable EmbracePlus device and data provided by patients with GTCS monitored in outpatient settings.
The secondary goals are:
to assess the clinical impact of SeizureWise on quality of life (QoL), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (QoL), psychological health indicators, and economic and clinical outcomes
A non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of SeizureWise to forecast GTCS occurrence and to assess impact on QoL and seizure management outcomes.
The study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. In a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.
- Conditions
- Epilepsy; Seizure
- Being tested
- SeizureWise algorithm, Multi-day Visualizations
- Keywords
- forecasting
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeizureWise algorithmDevice
An investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables
Multi-day VisualizationsDevice
Multi-day visualizations of sensor derived data
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise Receives: Device: Multi-day Visualizations |
| Personalized seizure risk score | Experimental | The personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, an investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables Receives: Device: SeizureWise algorithm; Device: Multi-day Visualizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of SeizureWise
Percentage of patients with (1) sensitivity of high-likelihood warnings greater than 60% and (2) superior to a rate-matched forecast (or superior baselining method) at the end of Phase 2.
Measured: 2 years
Secondary outcomes (6)
Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)
Changes in QoL and psychological health indicators pre- and post-Phase 3 (cross-arm and intra-arm comparisons. This will be assessed using the QOLIE-10-P and scored according to these guidelines https://www.aan.com/siteassets/home-page/policy-and-guidelines/quality/quality-measures/epilepsy-and-seizures/qolie10p-scoring.pdf
Measured: 2 years
Qualitative assessment of multi-day visualizations
Patient-reported qualitative assessment of multi-day visualizations to the patient during Phase 3 (both arms). This will be assessed using a custom survey and a qualitative analysis of the scores will be performed between start of phase 3 (with no visualizations) and during and at the end of phase 3 when visualizations have been provided to the user.
Measured: 2 years
Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)
Quantitative patient report of stress level pre- and post- forecast visualization during Phase 3 in the intervention arm. This will be assessed using brEASI-8 where a lower score indicates a lower stress level.
Measured: 2 years
Modifiable behavior change
Adjustment in modifiable behaviors during Phase 3 based on multi-day visualizations (boths arms) and forecast outputs (intervention arm). This will be assessed using a custom survey and a qualitative analysis will be performed that looks at participants behaviors before and after receiving visualizations and SeizureWise.
Measured: 2 years
Accuracy of SeizureWise low-likelihood forecast
Percentage of time in a low-likelihood forecast category during which no seizure event occurs during Phase 2.
Measured: 2 years
Accuracy of SeizureWise high-likelihood forecast
Percentage of time in a high-likelihood forecast category during which a seizure event occurs during Phase 2.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start11 Apr 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Empatica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275685
- Sponsor's protocol ID
- CIP-0001510
- Acronym
- Foresight
- Status last verified
- Sep 2024
- First submitted
- 8 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
- ClinicalTrials.gov ID
- NCT06275685
- Acronym / sponsor ID
- Foresight / CIP-0001510
- Conditions
- Epilepsy; Seizure
- Keywords
- forecasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Empatica, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Feb 2024 (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 goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.
The main questions it aims to answer are:
- can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
- does this tool improve the lives of people with epilepsy?
Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.
Detailed description
The primary goal of the study is to demonstrate the accuracy of SeizureWise in predicting the timing of future convulsive seizures using data collected by the wearable EmbracePlus device and data provided by patients with GTCS monitored in outpatient settings.
The secondary goals are:
to assess the clinical impact of SeizureWise on quality of life (QoL), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (QoL), psychological health indicators, and economic and clinical outcomes
A non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of SeizureWise to forecast GTCS occurrence and to assess impact on QoL and seizure management outcomes.
The study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. In a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Multi-day VisualizationsThe control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise |
| Personalized seizure risk score | Experimental | Device: SeizureWise algorithm, Device: Multi-day VisualizationsThe personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, an investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be diagnosed with or be at risk of epilepsy
- Subjects or their parents or guardians must understand and consent to be in the study;
- Subjects or their parents or guardians must be able to read and communicate in English;
- Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;
- Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.
Key exclusion criteria (4 listed)
- Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;
- Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);
- Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or
- Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.
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 |
|---|---|---|
| SeizureWise algorithmAn investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables | Device | Personalized seizure risk score |
| Multi-day VisualizationsMulti-day visualizations of sensor derived data | Device | Control, Personalized seizure risk score |
Primary outcome
Sensitivity of SeizureWise
Time frame: 2 years
Percentage of patients with (1) sensitivity of high-likelihood warnings greater than 60% and (2) superior to a rate-matched forecast (or superior baselining method) at the end of Phase 2.
6 secondary outcomes
Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)
Time frame: 2 years
Qualitative assessment of multi-day visualizations
Time frame: 2 years
Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)
Time frame: 2 years
Modifiable behavior change
Time frame: 2 years
Accuracy of SeizureWise low-likelihood forecast
Time frame: 2 years
Accuracy of SeizureWise high-likelihood forecast
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeizureWise algorithm and Multi-day Visualizations in people with Epilepsy; Seizure, run by Empatica, Inc. at 1 site in United States.
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 19 Sep 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Empatica Support (855-830-3531, support@empatica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of SeizureWise (time frame: 2 years). 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 19 Sep 2024.