Wearable device for detecting seizures
Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System
NA · University of Massachusetts, Worcester · NCT06598189
This study tests a new wearable device for detecting seizures in people with epilepsy to see if it works well and can help them feel more comfortable in their daily lives.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester (other) |
| Locations | 2 sites (Worcester, Massachusetts and 1 other locations) |
| Trial ID | NCT06598189 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of a wearable seizure detection device called EarSD in patients with epilepsy. Participants will wear the device while undergoing long-term video-EEG monitoring in the Epilepsy Monitoring Unit. The study aims to determine if the EarSD device can provide comfort, be unobtrusive during daily activities, and offer additional insights into seizure control. The results will be compared with conventional EEG recordings to assess the device's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted for long-term video-EEG monitoring for epilepsy.
Not a fit: Patients with cognitive impairments, those wearing other ear devices, or individuals who are pregnant or under 18 may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enhance seizure detection and improve the quality of life for patients with epilepsy.
How similar studies have performed: Other studies have shown promise in wearable seizure detection technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Worcester, Massachusetts and 1 other locations
- Ummmc-Memorial Campus — Worcester, Massachusetts, United States (RECRUITING)
- Ummmc-University Campus — Worcester, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Felicia Chu, MD — UMass Neurology Department
- Study coordinator: Stephanie Stephens
- Email: Stephanie.Stephens1@umassmed.edu
- Phone: 508-856-3939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Seizures, Epilepsy, Seizure Detection, Central Nervous System Diseases, Nervous System Diseases