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EpiCare@Home for Seizures
N/A
Recruiting
Led By Benjamin Vandendriessche, PhD
Research Sponsored by Byteflies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from emu admission to discharge, up to 10 days with an optional home use period of up to 14 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will study a device that monitors brain and physical activity to detect seizures in people with focal epilepsy. Participants wear it in the hospital and at home.
Eligible Conditions
- Partial seizures
- Partial Seizures
- Epilepsy
- Seizures
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from emu admission to discharge, up to 10 days with an optional home use period of up to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from emu admission to discharge, up to 10 days with an optional home use period of up to 14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sensitivity of algorithmic detection of potential epileptic events on EpiCare@Home data as compared to video-EEG ground truth annotations.
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.
Specificity of the classification of potential epileptic events as seizures by two independent trained reviewers as compared to video-EEG ground truth annotations.
Secondary study objectives
Compare the seizure duration as measured by EpiCare@Home to video-EEG ground truth annotations.
Interrater reliability (IRR) of the trained reviewers.
Post-analysis of the sensitivity of detection of potential epileptic events on subsets of data categorized based on seizure origin.
+1 moreOther study objectives
Assess the usability of the device via user surveys for healthcare professionals and patients.
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EpiCare@HomeExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
BytefliesLead Sponsor
5 Previous Clinical Trials
776 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
465 Previous Clinical Trials
176,773 Total Patients Enrolled
Benjamin Vandendriessche, PhDPrincipal InvestigatorByteflies
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known allergy to the materials used in the Byteflies Adhesives or any other biopotential electrode.You need to be observed in an EMU for at least 1 hour for medical reasons.Adults and adolescents who have a history or suspicion of focal onset epilepsy, including certain types of seizures.If you have certain implanted devices like pacemakers or cardioverter defibrillators that could be affected by magnets, you may not be able to participate. The risk will be looked at individually.
Research Study Groups:
This trial has the following groups:- Group 1: EpiCare@Home
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.