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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

Study 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
  • Epilepsy
  • Seizures
  • Focal Seizures

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and from emu admission to discharge, up to 10 days with an optional home use period of up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more
Other outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

BytefliesLead Sponsor
5 Previous Clinical Trials
776 Total Patients Enrolled
3 Trials studying Epilepsy
680 Patients Enrolled for Epilepsy
Thomas Jefferson UniversityOTHER
445 Previous Clinical Trials
145,634 Total Patients Enrolled
4 Trials studying Epilepsy
568 Patients Enrolled for Epilepsy
Benjamin Vandendriessche, PhDPrincipal InvestigatorByteflies

Media Library

EpiCare@Home Clinical Trial Eligibility Overview. Trial Name: NCT05738226 — N/A
Epilepsy Research Study Groups: EpiCare@Home
Epilepsy Clinical Trial 2023: EpiCare@Home Highlights & Side Effects. Trial Name: NCT05738226 — N/A
EpiCare@Home 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738226 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current count of participants in this experiment?

"Confirmed. The clinicaltrials.gov listing for this trial shows that it is currently recruiting participants and has been since January 23rd, 2023. 80 individuals need to be enrolled from 1 medical site; the last update was on February 10th, 2023."

Answered by AI

Is this experiment open to enrollment at the present time?

"Affirmative. According to the information present on clinicaltrials.gov, this trial is currently open for recruitment and has been since an initial post date of January 23rd 2023. The study's last edit was February 10th 2023 with a goal of recruiting 80 participants from 1 medical centre."

Answered by AI

What is the overarching objective of this research endeavor?

"This clinical trial intends to measure the sensitivity of algorithmic detection of potential epileptic events in EpiCare@Home study participants over a 10 day period as compared with video-EEG ground truth annotations. Other objectives include calculating sensitivity and specificity from seizure diary entries, evaluating the effect of seizure origin on data recall accuracy, and assessing interrater reliability (IRR) among trained reviewers."

Answered by AI
~36 spots leftby Apr 2025