Health TrialsbyHealthPanel

Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

ConditionEpilepsy; Seizure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorEmpatica, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • SeizureWise algorithm

    Device

    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 Visualizations

    Device

    Multi-day visualizations of sensor derived data

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Personalized seizure risk scoreExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Empatica, Inc.

Lead sponsor

Source ClinicalTrials.gov
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