Back to resultsEpiCare@Home Validation Study for Focal Onset Seizures
Primary Purpose
Epilepsy, Seizures, Seizures, Focal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EpiCare@Home, wearable multimodal seizure monitoring system
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring Wearable device, Seizure monitoring, Diagnostic support, EpiCare@Home, Clinical Decision Support (CDS)
Eligibility Criteria
Inclusion Criteria: Adult (age ≥ 18) and adolescent (12 ≤ age < 18) patients with a known history or suspicion of focal onset epilepsy, including focal-to-bilateral tonic-clonic seizures A clinical indication for ≥ 1 h EMU observation. Participants should be able to maintain a seizure diary in the provided EpiCare@Home Patient App (themselves or via a caregiver). Alternatively, the use of a paper seizure diary is allowed. Exclusion Criteria: Inability to provide written informed consent, either direct or via a proxy. Known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives or any 3rd party biopotential electrode. Having an implanted device may be grounds for exclusion, depending on the type and location of the implant. Implanted devices, such as (but not limited to) pacemakers, cardioverter defibrillators (ICD), and/or neural stimulation devices may contain magnetic switches. Byteflies Sensor Dots contain magnets that may interfere with the operation of these devices. The chance of this happening based on the strength of the magnets is exceedingly low (for comparison, the magnet strength is 10x lower than what is found in Apple Magsafe cases) but it has not been excluded by formal testing either. The risk will be evaluated on a case-by-case basis. Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
Sites / Locations
- Thomas Jefferson UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EpiCare@Home
Arm Description
Patients with a history or suspicion of focal onset epilepsy admitted to the EMU for routine observation will be able to opt-in to using EpiCare@Home during their admission. Optionally, they will be able to continue using the device at home after EMU discharge.
Outcomes
Primary Outcome Measures
Sensitivity of algorithmic detection of potential epileptic events on EpiCare@Home data as compared to video-EEG ground truth annotations.
Analytical validation of the algorithmic processing will be conducted by calculating the sensitivity (recall) of potential epileptic events and comparing it to ground truth annotations. The sensitivity is expected to be 65% or higher.
Sensitivity of algorithmic detection of potential epileptic events on a subset of temporal lobe epilepsy EpiCare@Home study participants as compared to video-EEG ground truth annotations.
Analytical validation of the algorithmic processing will be conducted by calculating the sensitivity (recall) of potential epileptic events and comparing it to ground truth annotations. The sensitivity is expected to be 85% or higher.
Specificity of the classification of potential epileptic events as seizures by two independent trained reviewers as compared to video-EEG ground truth annotations.
Clinical validation of the ability of trained reviewers to identify "real" seizures will be conducted by calculating the specificity of reviewed events and comparing it to ground truth annotations. The specificity is expected to be 95% or higher.
Secondary Outcome Measures
Compare the seizure duration as measured by EpiCare@Home to video-EEG ground truth annotations.
For confirmed seizures in both the EpiCare@Home and ground truth datasets, the length of each event is expected to be 85% similar.
Sensitivity and specificity of the potential epileptic events as detected by EpiCare@Home, compared to events recorded in a seizure diary.
In the optional home portion of the study, participants will be asked to keep a seizure diary. The events recorded in that diary will be compared to validated seizures in the EpiCare@Home dataset to calculate sensitivity and specificity.
Post-analysis of the sensitivity of detection of potential epileptic events on subsets of data categorized based on seizure origin.
A post-analysis will be performed to quantify the effect of seizure origin on the sensitivity (recall) of potential epileptic events, as compared to video-EEG ground truth annotations.
Interrater reliability (IRR) of the trained reviewers.
The IRR of the trained annotators who conduct clinical validation will be calculated and used to consider if the training was sufficient. A moderate or better reliability (IRR > 0.60) is expected.
Full Information
NCT ID
NCT05738226
First Posted
February 1, 2023
Last Updated
February 10, 2023
Sponsor
Byteflies
Collaborators
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05738226
Brief Title
EpiCare@Home Validation Study for Focal Onset Seizures
Official Title
Validation Study for Monitoring of Focal Onset Epileptic Seizures With a Wearable Seizure Monitoring Device, EpiCare@Home
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Byteflies
Collaborators
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures. The device continuously records brain, cardiorespiratory, and physical activity data.
The study aims to 1) collect benchmark data for seizure detection algorithm development and validation, and 2) evaluate the performance of the device in clinical and at home workflows.
Participants will wear the device during a routine Epilepsy Monitoring Unit (EMU) admission. Additionally, they can continue wearing the device at home after the EMU admission.
Detailed Description
Epilepsy, a neurological disorder characterized by recurrent epileptic seizures of often complex etiology, affects 65 million people globally. The current reference for home use is self-reported outcomes (typically via a seizure diary) which leads to significant under and inaccurate reporting of seizures. As seizure counting is the basis for many medical decisions, the ability to accurately and unobtrusively log seizures during activities of daily living would: 1) improve clinical practice by reducing the need for patients to spend time in an Epilepsy Monitoring Unit (EMU) and more quickly identify an appropriate treatment plan; and 2) provide a means to collect real-world data (RWD) for research and clinical purposes.
EpiCare@Home is a multimodal device that can continuously record EEG with unobtrusive behind-the-ear electrodes, in addition to cardiorespiratory and physical motion data. The device is intended to be used by a trained healthcare professional (HCP) as a clinical decision support tool during the management of people with epilepsy.
The clinical trial aims to analytically validate the performance of the seizure detection component of the device, specifically for focal onset seizures. In addition, it intends to clinically validate the ability of the device to support clinical workflows, from the perspective of healthcare professional and patient users alike.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizures, Seizures, Focal, Seizure, Refractory
Keywords
Wearable device, Seizure monitoring, Diagnostic support, EpiCare@Home, Clinical Decision Support (CDS)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EpiCare@Home
Arm Type
Experimental
Arm Description
Patients with a history or suspicion of focal onset epilepsy admitted to the EMU for routine observation will be able to opt-in to using EpiCare@Home during their admission. Optionally, they will be able to continue using the device at home after EMU discharge.
Intervention Type
Device
Intervention Name(s)
EpiCare@Home, wearable multimodal seizure monitoring system
Intervention Description
Two wearable devices (Byteflies Sensor Dots) will be used. One Sensor Dot will be placed in the neck with a skin adhesive and will be connected to EEG electrodes placed behind each ear. The second Sensor Dot will be placed on the chest with an adhesive ECG electrode (i.e., a cardiac "patch").
Primary Outcome Measure Information:
Title
Sensitivity of algorithmic detection of potential epileptic events on EpiCare@Home data as compared to video-EEG ground truth annotations.
Description
Analytical validation of the algorithmic processing will be conducted by calculating the sensitivity (recall) of potential epileptic events and comparing it to ground truth annotations. The sensitivity is expected to be 65% or higher.
Time Frame
From EMU admission to discharge, up to 10 days
Title
Sensitivity of algorithmic detection of potential epileptic events on a subset of temporal lobe epilepsy EpiCare@Home study participants as compared to video-EEG ground truth annotations.
Description
Analytical validation of the algorithmic processing will be conducted by calculating the sensitivity (recall) of potential epileptic events and comparing it to ground truth annotations. The sensitivity is expected to be 85% or higher.
Time Frame
From EMU admission to discharge, up to 10 days
Title
Specificity of the classification of potential epileptic events as seizures by two independent trained reviewers as compared to video-EEG ground truth annotations.
Description
Clinical validation of the ability of trained reviewers to identify "real" seizures will be conducted by calculating the specificity of reviewed events and comparing it to ground truth annotations. The specificity is expected to be 95% or higher.
Time Frame
From EMU admission to discharge, up to 10 days
Secondary Outcome Measure Information:
Title
Compare the seizure duration as measured by EpiCare@Home to video-EEG ground truth annotations.
Description
For confirmed seizures in both the EpiCare@Home and ground truth datasets, the length of each event is expected to be 85% similar.
Time Frame
From EMU admission to discharge, up to 10 days
Title
Sensitivity and specificity of the potential epileptic events as detected by EpiCare@Home, compared to events recorded in a seizure diary.
Description
In the optional home portion of the study, participants will be asked to keep a seizure diary. The events recorded in that diary will be compared to validated seizures in the EpiCare@Home dataset to calculate sensitivity and specificity.
Time Frame
From EMU discharge until the end of the home use period, for up to 14 days
Title
Post-analysis of the sensitivity of detection of potential epileptic events on subsets of data categorized based on seizure origin.
Description
A post-analysis will be performed to quantify the effect of seizure origin on the sensitivity (recall) of potential epileptic events, as compared to video-EEG ground truth annotations.
Time Frame
From EMU admission to discharge, up to 10 days
Title
Interrater reliability (IRR) of the trained reviewers.
Description
The IRR of the trained annotators who conduct clinical validation will be calculated and used to consider if the training was sufficient. A moderate or better reliability (IRR > 0.60) is expected.
Time Frame
From EMU admission to discharge, up to 10 days
Other Pre-specified Outcome Measures:
Title
Evaluate device performance by comparing the total length of recorded usable data with EpiCare@Home to video-EEG or the expected recording time at home.
Description
Usable data is defined as data that an expert reviewer can read and interpret. The length of recorded data with EpiCare@Home will be compared against the expected recording length, either based on video-EEG timing or prescribed home use period.
Time Frame
From EMU admission to discharge, up to 10 days with an optional home use period of up to 14 days
Title
Assess the usability of the device via user surveys for healthcare professionals and patients.
Description
Surveys will be provided to patients at the end of study participation and healthcare professionals will be interviewed about their experience with the device. Surveys will be scored on a 5-point Likert scale ([1] strongly disagree, [5] strongly agree).
Time Frame
From EMU admission to discharge, up to 10 days with an optional home use period of up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (age ≥ 18) and adolescent (12 ≤ age < 18) patients with a known history or suspicion of focal onset epilepsy, including focal-to-bilateral tonic-clonic seizures
A clinical indication for ≥ 1 h EMU observation.
Participants should be able to maintain a seizure diary in the provided EpiCare@Home Patient App (themselves or via a caregiver). Alternatively, the use of a paper seizure diary is allowed.
Exclusion Criteria:
Inability to provide written informed consent, either direct or via a proxy.
Known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives or any 3rd party biopotential electrode.
Having an implanted device may be grounds for exclusion, depending on the type and location of the implant. Implanted devices, such as (but not limited to) pacemakers, cardioverter defibrillators (ICD), and/or neural stimulation devices may contain magnetic switches. Byteflies Sensor Dots contain magnets that may interfere with the operation of these devices. The chance of this happening based on the strength of the magnets is exceedingly low (for comparison, the magnet strength is 10x lower than what is found in Apple Magsafe cases) but it has not been excluded by formal testing either. The risk will be evaluated on a case-by-case basis.
Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waverlee Harvey, BSc
Phone
+32 32 94 74 99
Email
waverlee.harvey@byteflies.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Nys, PhD
Phone
+32 32 94 74 99
Email
julie.nys@byteflies.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Vandendriessche, PhD
Organizational Affiliation
Byteflies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sperling, MD
Phone
215-955-1222
Email
michael.sperling@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Jessica Rinaldi, BA
Phone
+1 (215) 955-4672
Email
jessica.rinaldi@jefferson.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29295522
Citation
Gu 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.
Results Reference
background
PubMed Identifier
32160324
Citation
Vandecasteele 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.
Results Reference
background
PubMed Identifier
32563052
Citation
Boada CM, French JA, Dumanis SB. Proceedings of the 15th Antiepileptic Drug and Device Trials Meeting: State of the Science. Epilepsy Behav. 2020 Oct;111:107189. doi: 10.1016/j.yebeh.2020.107189. Epub 2020 Jun 17.
Results Reference
background
PubMed Identifier
34240748
Citation
Vandecasteele K, De Cooman T, Chatzichristos C, Cleeren E, Swinnen L, Macea Ortiz J, Van Huffel S, Dumpelmann M, Schulze-Bonhage A, De Vos M, Van Paesschen W, Hunyadi B. The power of ECG in multimodal patient-specific seizure monitoring: Added value to an EEG-based detector using limited channels. Epilepsia. 2021 Oct;62(10):2333-2343. doi: 10.1111/epi.16990. Epub 2021 Jul 9.
Results Reference
background
PubMed Identifier
34490891
Citation
Swinnen L, Chatzichristos C, Jansen K, Lagae L, Depondt C, Seynaeve L, Vancaester E, Van Dycke A, Macea J, Vandecasteele K, Broux V, De Vos M, Van Paesschen W. Accurate detection of typical absence seizures in adults and children using a two-channel electroencephalographic wearable behind the ears. Epilepsia. 2021 Nov;62(11):2741-2752. doi: 10.1111/epi.17061. Epub 2021 Sep 7.
Results Reference
background
Links:
URL
https://www.byteflies.com/epicarehome
Description
EpiCare@Home product website
Learn more about this trial
EpiCare@Home Validation Study for Focal Onset Seizures
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