Ear-Seizure Detection (EarSD) Study

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
Felicia Chu
Study ID
NCT06598189
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ear-SD — DEVICE
    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.
  • Electroencephalogram — DIAGNOSTIC_TEST
    Standard 21-channel scalp-continuous electroencephalogram (cEEG) with video recording and electrocardiogram (ECG)

Study Details

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.

Key Dates

Start date
Apr 3, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Seizure Recording Criteria 1 [ Time Frame: Through study completion, an average of 7 Days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ummmc-Memorial CampusWorcesterMassachusetts01655
Stephanie Stephens, BS
[email protected]
(508) 856-3939
Charles Hill, BS
[email protected]
(508) 856 4667
Felicia Chu, MD (PRINCIPAL_INVESTIGATOR)
Ummmc-University CampusWorcesterMassachusetts01655
Stephanie Stephens, BS
[email protected]
508) 856-3939
Charles Hill, BS
[email protected]
(508) 856 4667
Felicia Chu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Worcester, MA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Ummmc-Memorial Campus· Worcester, MAUmmmc-University Campus· Worcester, MA

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