Clinical trial NCT06598189: Ear-Seizure Detection (EarSD) Study
Official title: Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Seizures
Epilepsy
Keywords: Seizure Detection
Central Nervous System Diseases
Nervous System Diseases
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Amherst
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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: 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)

Primary outcomes:
measure: Seizure Recording Criteria 1
timeFrame: Through study completion, an average of 7 Days
measure: Seizure Recording Criteria 2
timeFrame: Through study completion, an average of 7 Days
measure: Seizure Recording Criteria 3
timeFrame: Through study completion, an average of 7 Days
measure: Data Interpretation
timeFrame: up to 2 years
measure: Seizure Accuracy/Prediction
timeFrame: up to 5 years
Secondary outcomes:
measure: Qualitative Satisfaction Survey
timeFrame: Through study completion, an average of 7 Days
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Ummmc-Memorial Campus
state: Massachusetts
city: Worcester
country: United States
facility: Ummmc-University Campus
state: Massachusetts
Study officials:
affiliation: UMass Neurology Department
name: Felicia Chu, MD
role: PRINCIPAL_INVESTIGATOR
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