Ear-Seizure Detection (EarSD) Study
NCT06598189 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-10-28
Summary
The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.
Conditions
Interventions
- DEVICE
-
Ear-SD
The Ear-SD is a purely EEG recording device Continuous Electroencephalogram (cEEG), Electromyogram (EMG), Electrooculogram (EOG), Photoplethysmogram (PPG), Electrodermoactivity (EDA), and Inertial Measurement Unit (IMU). The Ear-SD device rests on the ears and connects to the scalp by two sticker electrodes.
- DIAGNOSTIC_TEST
-
Electroencephalogram
Standard 21-channel scalp-continuous electroencephalogram (cEEG) with video recording and electrocardiogram (ECG)
Sponsors & Collaborators
-
University of Massachusetts, Amherst
collaborator OTHER -
Felicia Chu
lead OTHER
Principal Investigators
-
Felicia Chu, MD · UMass Neurology Department
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-03
- Primary Completion
- 2027-12-31
- Completion
- 2032-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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