Development of a Minimally Invasive Seizure Gauge
Study Details
Study Description
Brief Summary
The researchers are trying to assess changes in physiological signals before and during seizures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Subjects that are undergoing video EEG monitoring in their home for their epilepsy at Seer Medical will be consented to participate in this study for a minimum of two days and/or the duration of their monitoring period for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys.
When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Monitoring Device Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv |
Device: EpiTel Epilog
EEG recording device
Device: Empatica E4
PPG, sweat level, temperature and accelerometry recording device
Device: GENEActiv
Temperature, light level and accelerometry recording device
|
Outcome Measures
Primary Outcome Measures
- Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors [2-7 days approximately]
We will collect physiological signals with the three wearable, noninvasive biosensors in Seer Medical patients undergoing scalp-recorded video EEG-ECG as part of their clinical epilepsy evaluation. These signals include temperature, light level, EEG, heart rate, galvanic skin response, PPG, accelerometry. We will evaluate biosignals based on reliability to detect seizures.
- Wearable Sensors Comfort Assessment [2-7 days approximately]
We will collect physiological signals with the three wearable, noninvasive biosensors in Seer Medical patients. We will evaluate subject comfort and ease of use for each device, measured through quantitative surveys.
- Seizure Detection and Prediction using Multimodal Physiological Data [2-7 days approximately]
We will apply data mining and machine learning methods to identify patterns in the collected physiological signals and correlate these patterns with the timing of seizures identified by the patient's clinical video-EEG monitoring. We will use sensitivity and specificity measures to determine which signals are most useful in detecting and predicting seizure events.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with epilepsy undergoing scalp EEG for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures
-
Patients of age 18 or above
Exclusion Criteria:
- Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seer Medical | Melbourne | Victoria | Australia | 3000 |
Sponsors and Collaborators
- Seer Medical Pty Ltd
Investigators
- Principal Investigator: Dean R Freestone, PhD BEng, CEO
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HREC042_18