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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Ear-SD for epilepsy?

The research highlights that wearable seizure detection devices, which include sensors similar to those potentially used in Ear-SD, can improve the quality of life for epilepsy patients by accurately detecting seizures and reducing underreporting. These devices, especially those with accelerometry and surface electromyography sensors, have shown high performance in detecting seizures, which suggests that similar technology in Ear-SD could be effective. ^{1 2 3 4 5}

Is the wearable device for epilepsy safe for humans?

The wearable device, including the Ear-EEG, has been tested in both epileptic patients and healthy individuals for seizure detection and sleep recordings, showing it is generally safe for human use. Additionally, the Mayo Epilepsy Personal Assistant Device (EPAD) underwent extensive testing in animals and is currently in human trials, indicating a focus on safety and regulatory compliance. ^{1 6 7 8 9}

How does the Ear-SD treatment for epilepsy differ from other treatments?

The Ear-SD treatment is unique because it involves a wearable device that can monitor brain activity and predict seizures, allowing for adaptive neuromodulation therapy. This approach is different from traditional treatments like medication or surgery, as it provides real-time data and personalized seizure management. ^{1 5 7 10 11}

Research Team

Felicia Chu, MD

Principal Investigator

UMass Neurology Department

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Wearable seizure detection devices in refractory epilepsy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Day and night comfort and stability on the body of four wearable devices for seizure detection: A direct user-experience. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

An electroencephalographic recording platform for real-time seizure detection. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Preferences and User Experiences of Wearable Devices in Epilepsy: A Systematic Review and Mixed-Methods Synthesis. [2022]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Ear-EEG-based sleep scoring in epilepsy: A comparison with scalp-EEG. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Ultra-long-term subcutaneous home monitoring of epilepsy-490 days of EEG from nine patients. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Signal quality and patient experience with wearable devices for epilepsy management. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Mobile seizure monitoring in epilepsy patients]. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Visual seizure annotation and automated seizure detection using behind-the-ear electroencephalographic channels. [2020]