Development of a Practical, Minimally Invasive Seizure Gauge
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Mayo Clinic
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Pattern Analysis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Benjamin H. Brinkmann
Principal Investigator
Mayo Clinic
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Pattern Analysis
Time Frame: 2-10 days approximately
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.
Assessment of Physiological Signals Measurable with Wearable Sensors
Time Frame: 2-10 days approximately
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.