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Behavioural Intervention

Wearable Device for Epilepsy (EarSD001 Trial)

N/A

Waitlist Available

Led By Felicia Chu, MD

Research Sponsored by Felicia Chu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Must not have

Cognitive impaired individuals

Children (Age 0-17)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test how well a wearable device called EarSD can detect and predict seizures in patients with epilepsy. They will compare the results from the EarSD device with conventional video-EEG recordings

Who is the study for?

This trial is for individuals with epilepsy who experience seizures and are being monitored in a hospital's Epilepsy Monitoring Unit. Specific eligibility criteria details were not provided.

What is being tested?

The study is testing the accuracy of EarSD, a wearable device designed to detect and predict seizures, by comparing its recordings with those from standard video-EEG monitoring.

What are the potential side effects?

Potential side effects are not detailed, but as this involves non-invasive monitoring with EarSD and EEG, risks may be minimal compared to drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive impairment.

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I am under 18 years old.

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I have skin irritation where the device will be placed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Data Interpretation

Seizure Accuracy/Prediction

Seizure Recording Criteria 1

+2 more

Secondary study objectives

Qualitative Satisfaction Survey

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: Ear-Worn GroupExperimental Treatment2 Interventions

All consented patients admitted to the Epilepsy Monitoring Unit (EMU) who are on continuous EEG (cEEG) will wear the ear-worn seizure detection device (EarSD) and there will be no randomization. The Ear-SD Device will be simultaneously worn by EMU patients on continuous video 21 electrode EEG (International 10-20 system) and single channel electrocardiogram (ECG). Daily skin assessment will be conducted and electrodes will be replaced as needed. At the end of the study, a self-reported short qualitative survey will be conducted to assess the overall experience of the enrolled subjects. The EarSD device and electrodes will be removed at the end of the study with the last skin examination.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electroencephalogram

2012

N/A

~150

0 / 4Eligibility criteria met