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Device

Continuous Electrographic Monitoring for Epilepsy

N/A
Waitlist Available
Research Sponsored by Epitel, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous diagnosis of Epilepsy or other seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new,Patch-type telemetry device for simplified, single-channel EEG recording from human patients.

Who is the study for?
This trial is for individuals aged 5 and older with a previous epilepsy diagnosis, who are scheduled for at least an overnight EEG test. It's not suitable for those allergic to adhesives.
What is being tested?
The study observes how patients interact with a seizure forecasting app while using a wireless, patch-type EEG device compared to traditional wired EEG monitoring in the hospital.
What are the potential side effects?
Since this is an observational study involving psychological and behavioral interaction with an app and non-invasive monitoring, there are no direct medical side effects from interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with epilepsy or another seizure disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity and specificity for prospective seizure alerting
Sensitivity and specificity for retrospect seizure detection
Sensitivity and specificity fro prospective seizure forecasting
+1 more

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: Entire StudyExperimental Treatment3 Interventions
Each patient is eligible for all interventions in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Observational only
2020
N/A
~130

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER
1,805 Previous Clinical Trials
2,821,596 Total Patients Enrolled
6 Trials studying Epilepsy
492 Patients Enrolled for Epilepsy
Epitel, Inc.Lead Sponsor
3 Previous Clinical Trials
238 Total Patients Enrolled
2 Trials studying Epilepsy
194 Patients Enrolled for Epilepsy
Boston Children's HospitalOTHER
785 Previous Clinical Trials
5,580,981 Total Patients Enrolled
21 Trials studying Epilepsy
8,321 Patients Enrolled for Epilepsy

Media Library

Wireless EEG Patch (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03583957 — N/A
Epilepsy Research Study Groups: Entire Study
Epilepsy Clinical Trial 2023: Wireless EEG Patch Highlights & Side Effects. Trial Name: NCT03583957 — N/A
Wireless EEG Patch (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03583957 — N/A
~134 spots leftby Apr 2026