Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Massachusetts
Ummmc-Memorial Campus
RECRUITING
Worcester
Ummmc-University Campus
RECRUITING
Worcester
Contact Information
Primary
Stephanie Stephens
Stephanie.Stephens1@umassmed.edu
508-856-3939
Backup
Charles Hill
Charles.hill6@umassmed.edu
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2032-12
Participants
Target number of participants: 40
Treatments
Experimental: Ear-Worn Group
All consented patients admitted to the Epilepsy Monitoring Unit (EMU) who are on continuous EEG (cEEG) will wear the ear-worn seizure detection device (EarSD) and there will be no randomization.~The Ear-SD Device will be simultaneously worn by EMU patients on continuous video 21 electrode EEG (International 10-20 system) and single channel electrocardiogram (ECG). Daily skin assessment will be conducted and electrodes will be replaced as needed. At the end of the study, a self-reported short qualitative survey will be conducted to assess the overall experience of the enrolled subjects. The EarSD device and electrodes will be removed at the end of the study with the last skin examination.
Sponsors
Collaborators: University of Massachusetts, Amherst
Leads: Felicia Chu