Wearable Device for Epilepsy

(EarSD001 Trial)

Recruiting at 1 trial location

Overseen By Charles Hill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Felicia Chu

Disqualifiers: Hearing aids, Intracranial electrodes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 7 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device designed to detect and predict seizures in people with epilepsy. Worn on the ear, the device is compared to traditional methods that use video and EEG (a test that records brain activity) in a hospital setting. It suits adults admitted to the epilepsy monitoring unit who are willing to try this device and do not use other ear devices like hearing aids. Participants will share their experiences using the device at the trial's end. As an unphased trial, this study allows participants to contribute to innovative research that could enhance seizure detection and prediction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a wearable device to monitor seizures, so you may not need to change your medication routine.

What prior data suggests that this wearable device is safe for epilepsy patients?

Research has shown that the Ear-Seizure Detection (EarSD) device is generally safe to use. It has been tested on individuals with and without epilepsy. The device is designed for comfort and ease of wear. Studies have not identified any major problems or harmful effects from its use.

The device uses standard, commonly available parts, ensuring reliability and safety. It has accurately detected seizures, an important safety feature. Users have not reported significant discomfort while wearing it, and daily skin checks are conducted to ensure no issues arise.

Overall, current research indicates that the EarSD device is well-tolerated and safe for people with epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ear-SD device for epilepsy because it offers a unique, non-invasive way to monitor seizures. Unlike current treatments that often rely on medication and invasive procedures, this wearable device continuously tracks brain activity through an ear-worn sensor, providing real-time seizure detection alongside traditional EEG and ECG monitoring. This could lead to more immediate intervention and personalized care, potentially improving the quality of life for people with epilepsy.

What evidence suggests that this wearable device is effective for epilepsy?

Research has shown that the Ear-Seizure Detection Device (EarSD), used by participants in this trial, can identify seizures with high accuracy. One study detected seizures with up to 93.5% accuracy in 33 patients. Another study found it reached up to 95.3% accuracy using advanced computer programs. These results suggest that EarSD could serve as a promising alternative to traditional EEG systems for detecting seizures. It offers several benefits, such as increased comfort and ease of use, making it a convenient choice for people with epilepsy. ^{1 3 5 6 7}

Who Is on the Research Team?

Felicia Chu, MD

Principal Investigator

UMass Neurology Department

Are You a Good Fit for This Trial?

This trial is for individuals with epilepsy who experience seizures and are being monitored in a hospital's Epilepsy Monitoring Unit. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am admitted to UMass for long-term epilepsy monitoring.

Ability to provide informed consent

Willing to wear the wearable device

Exclusion Criteria

Inability or unwillingness to provide informed consent

I have cognitive impairment.

Subjects wearing other ear devices such as hearing aids

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the EarSD device and are monitored with continuous EEG and ECG during hospitalization

7 days

Continuous monitoring during hospitalization

Follow-up

Participants complete a qualitative satisfaction survey and final skin examination after device removal

1 day

1 visit (in-person)

Data Interpretation

Data from EarSD and cEEG are analyzed for seizure detection and prediction accuracy

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Ear-SD

Trial Overview The study is testing the accuracy of EarSD, a wearable device designed to detect and predict seizures, by comparing its recordings with those from standard video-EEG monitoring.

How Is the Trial Designed?

Group I: Ear-Worn Group Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Felicia Chu

Lead Sponsor

Trials

1

Recruited

40+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Published Research Related to This Trial

The Mayo Epilepsy Personal Assistant Device (EPAD) is designed to enhance seizure prediction and management by integrating with the Medtronic Summit RC+STM device for real-time monitoring of brain activity, which could improve the effectiveness of neuromodulation therapy.

The EPAD system is currently undergoing a first-in-human trial involving ten patients with difficult-to-treat epilepsy, following extensive testing on canines, indicating a strong commitment to safety and regulatory compliance in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. Pal Attia, T., Crepeau, D., Kremen, V., et al.[2022]

The study demonstrated that home monitoring of epilepsy patients using a subcutaneous EEG device is feasible and well tolerated, with no serious adverse events reported among the nine participants over a monitoring period of up to 3 months.

The device provided objective seizure counts that often differed significantly from patients' self-reported seizure diaries, revealing underreporting and important insights into seizure patterns and responses to antiepileptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-long-term subcutaneous home monitoring of epilepsy-490 days of EEG from nine patients. Weisdorf, S., Duun-Henriksen, J., Kjeldsen, MJ., et al.[2021]

Wearable seizure detection devices (WSDDs) can significantly enhance the quality of life for epilepsy patients by improving seizure detection, which may lead to better care and potentially prevent sudden unexpected death in epilepsy.

Among the 16 WSDDs reviewed, those using accelerometry and surface electromyography showed the highest performance in detecting tonic-clonic seizures, emphasizing the need for standardized testing to improve device development and comparison.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable seizure detection devices in refractory epilepsy. Verdru, J., Van Paesschen, W.[2023]

Wearable devices are becoming increasingly important for epilepsy management, as they can effectively monitor seizure frequency and provide warnings for impending seizures, enhancing patient safety.

Current technology allows for the documentation of nocturnal motor seizures, and various parameters like accelerometry and heart rate are used to capture seizure manifestations, indicating a promising direction for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile seizure monitoring in epilepsy patients]. Schulze-Bonhage, A., Böttcher, S., Glasstetter, M., et al.[2020]

The wearable device (Sensor Dot) demonstrated a focal seizure detection sensitivity of 52% in hospitalized patients and 23% in outpatients, indicating that while it can detect some seizures, its overall performance is limited by high false alarm rates and low predictive values.

Patient feedback showed that the device was generally well-received, but side effects led to a dropout rate, highlighting the need for improvements in both device performance and user experience for better clinical implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-hospital and home-based long-term monitoring of focal epilepsy with a wearable electroencephalographic device: Diagnostic yield and user experience. Macea, J., Bhagubai, M., Broux, V., et al.[2023]

Citations

1. arxiv.org arxiv.org/html/2401.05425v1

An Unobtrusive and Lightweight Ear-worn System for ... The preliminary results confirm that EarSD is able to detect seizure with up to 93.5% accuracy on 33 patients.

2. dl.acm.org dl.acm.org/doi/10.1145/3703164

An Unobtrusive and Lightweight Ear-worn System for ... Ear-worn devices offer a promising alternative to traditional EEG systems for seizure detection, offering several advantages over scalp EEG and other wearable ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38376923/

Real-Time Seizure Detection Using Behind-the-Ear ... This study examines the usability and comfort of a behind-the-ear seizure detection device called brain seizure detection (BrainSD)

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06598189/ear-seizure-detection-earsd-study

Ear-Seizure Detection (EarSD) Study The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device ( ...

5. researchgate.net researchgate.net/publication/380427240_An_Unobtrusive_and_Lightweight_Ear-worn_System_for_Continuous_Epileptic_Seizure_Detection

An Unobtrusive and Lightweight Ear-worn System for ... The preliminary results confirm that EarSD can detect seizures with up to 95.3% accuracy by just using classical machine learning algorithms.

6. app.trialscreen.org app.trialscreen.org/trials/ear-seizure-detection-earsd-trial-nct06598189

Ear-Seizure Detection (EarSD) Study Benefits: Participation in this study may help in the development of a more comfortable, unobtrusive, and insightful seizure detection and prediction device, ...

7. withpower.com withpower.com/trial/wearable-device-for-epilepsy-1bcc9

Wearable Device for Epilepsy (EarSD001 Trial) The wearable device, including the Ear-EEG, has been tested in both epileptic patients and healthy individuals for seizure detection and sleep recordings, ...