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Development of a Practical, Minimally Invasive Seizure Gauge

Development of a Practical, Minimally Invasive Seizure Gauge

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03745118
Enrollment
95
Registered
2018-11-19
Start date
2018-11-19
Completion date
2022-08-05
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Seizure

Brief summary

The researchers are trying to assess changes in physiological signals before and during seizures.

Detailed description

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.

Interventions

Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel

DEVICEByte Flies Sensor Dots

Plastic pads that will be adhered to your chest area

wearable seizure detection wristband

DEVICEBiovotion Everion

wearable seizure detection device armband that is attached to upper arm

DEVICEGeneActiv

wearable seizure detection watch

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g. NeuroPace RNS, Medtronic PC+S, Medtronic RC+S) * Pediatric subjects 7 years of age or older.

Exclusion criteria

* Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices. * Presence of open or healing wounds near monitoring sites (infection risk).

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Physiological Signals Measurable with Wearable Sensors2-10 days approximatelyWe 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.
Pattern Analysis2-10 days approximatelyWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026