NCT06275685

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

February 8, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

February 8, 2024

Last Update Submit

September 10, 2024

Conditions

Epilepsy; Seizure

Keywords

forecasting

Outcome Measures

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.

    2 years

Secondary Outcomes (6)

  • Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)

    2 years

  • Qualitative assessment of multi-day visualizations

    2 years

  • Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)

    2 years

  • Modifiable behavior change

    2 years

  • Accuracy of SeizureWise low-likelihood forecast

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise

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

Device: SeizureWise algorithmDevice: Multi-day Visualizations

Interventions

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

Personalized seizure risk score
Multi-day VisualizationsDEVICE

Multi-day visualizations of sensor derived data

ControlPersonalized seizure risk score

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Empatica

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Empatica Support

CONTACT

855-830-3531support@empatica.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 23, 2024

Study Start

April 11, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)