An interventional study of EpiTel EpiLog and Byte Flies Sensor Dots in Epilepsy, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
The researchers are trying to assess changes in physiological signals before and during seizures.
Subjects that are undergoing video EEG monitoring in the hospital for their epilepsy at Mayo Clinic will be consented to participate in this study for a minimum of two days and/or the duration of their hospital stay for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys.
In the second year of the study patients who have implanted devices capable of recording or detecting seizures will be recruited to wear a noninvasive biosensor for multiple months. This data will be used to develop algorithms capable of detecting and/or forecasting seizures.
When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 95 is above the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be asked to wear up to 4 different noninvasive seizure detection devices including EpiTel EpiLog, Byte Flies Sensor Dots, Empatica E4, Biovotion Everion, GeneActiv
Device: EpiTel EpiLog · Device: Byte Flies Sensor Dots · Device: Empatica E4 · Device: Biovotion Everion · Device: GeneActiv
Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel
Also known as: Epilog
Plastic pads that will be adhered to your chest area
Also known as: Byteflies, Sensor Dots
wearable seizure detection wristband
Also known as: E4 Wristband
wearable seizure detection device armband that is attached to upper arm
wearable seizure detection watch
Assessment of Physiological Signals Measurable with Wearable Sensors
We will collect physiological signals with the five wearable, noninvasive biosensors listed below in Mayo patients undergoing scalp-recorded video EEG and invasive stereotactic EEG/video monitoring as part of their clinical epilepsy evaluation. We will evaluate biosignals based on data quality and reliability, and subject comfort and ease of use.
Time frame: 2-10 days approximately
Pattern Analysis
We will apply data mining and machine learning methods to search for patterns in the collected physiological signals and correlate these patterns with the timing of seizures identified by the patient's clinical video-EEG monitoring.
Time frame: 2-10 days approximately
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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