Development of a Minimally Invasive Seizure Gauge
Primary Purpose
Epilepsy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
EpiTel Epilog
Empatica E4
GENEActiv
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy
Eligibility 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.
Sites / Locations
- Seer Medical
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monitoring Device
Arm Description
Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv
Outcomes
Primary Outcome Measures
Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03882671
Brief Title
Development of a Minimally Invasive Seizure Gauge
Official Title
Development of a Minimally Invasive Seizure Gauge
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seer Medical Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monitoring Device
Arm Type
Experimental
Arm Description
Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv
Intervention Type
Device
Intervention Name(s)
EpiTel Epilog
Intervention Description
EEG recording device
Intervention Type
Device
Intervention Name(s)
Empatica E4
Intervention Description
PPG, sweat level, temperature and accelerometry recording device
Intervention Type
Device
Intervention Name(s)
GENEActiv
Intervention Description
Temperature, light level and accelerometry recording device
Primary Outcome Measure Information:
Title
Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors
Description
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.
Time Frame
2-7 days approximately
Title
Wearable Sensors Comfort Assessment
Description
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.
Time Frame
2-7 days approximately
Title
Seizure Detection and Prediction using Multimodal Physiological Data
Description
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.
Time Frame
2-7 days approximately
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean R Freestone, PhD BEng
Organizational Affiliation
CEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seer Medical
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Development of a Minimally Invasive Seizure Gauge
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