NCT06598189NARecruitingAccepts Healthy Volunteers

Ear-Seizure Detection (EarSD) Study

Felicia Chu

Start Date

4/3/2025

Completion Date

12/1/2032

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.

Detailed Description

A wearable seizure detection and prediction device (EarSD) is worn by patients with epileptic seizures. In this study, the goal is to validate the accuracy of a newly developed portable seizure detection device by examining if the Ear-SD device can (1) provide more comfort, (2) be unobtrusive to the subject during daily activities, and (3) be able to provide additional insight on a patients' seizure control.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

DEVICE

Ear-SD

DIAGNOSTIC_TEST

Electroencephalogram

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Conditions

SeizuresEpilepsy

Locations

Ummmc-Memorial Campus

Worcester, Massachusetts 01655

United States

Ummmc-University Campus

Worcester, Massachusetts 01655

United States