RecruitingNot ApplicableNCT06598189

Ear-Seizure Detection (EarSD) Study

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


Sponsor

Felicia Chu

Enrollment

40 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥ 18 years.
  • 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.
  • Willing to wear the wearable device.
  • Ability to provide informed consent

Exclusion Criteria8

  • Subjects wearing other ear devices such as hearing aids.
  • Inability or unwillingness to provide informed consent.
  • Irritation of the skin where the device is to be placed.
  • Patients with intracranial electrodes placement.
  • Prisoners
  • Cognitive impaired individuals
  • Pregnant Women
  • Children (Age 0-17)

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Interventions

DEVICEEar-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_TESTElectroencephalogram

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

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NCT06598189


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