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RECRUITINGINTERVENTIONAL

Ear-Seizure Detection (EarSD) Study

Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years. 2. Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy. 3. Willing to wear the wearable device. 4. Ability to provide willing to sign a consent form Who Should NOT Join This Trial: 1. Subjects wearing other ear devices such as hearing aids. 2. Inability or unwillingness to provide willing to sign a consent form. 3. Irritation of the skin where the device is to be placed. 4. Patients with intracranial electrodes placement. 5. Prisoners 6. Cognitive impaired individuals 7. Pregnant Women 8. Children (Age 0-17) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy. 3. Willing to wear the wearable device. 4. Ability to provide informed consent Exclusion Criteria: 1. Subjects wearing other ear devices such as hearing aids. 2. Inability or unwillingness to provide informed consent. 3. Irritation of the skin where the device is to be placed. 4. Patients with intracranial electrodes placement. 5. Prisoners 6. Cognitive impaired individuals 7. Pregnant Women 8. Children (Age 0-17)

Treatments Being Tested

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)

Locations (2)

Ummmc-Memorial Campus
Worcester, Massachusetts, United States
Ummmc-University Campus
Worcester, Massachusetts, United States