Development of a Minimally Invasive Seizure Gauge

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy
• Intervention / Treatment: Device: EpiTel Epilog; Device: Empatica E4; Device: GENEActiv

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Seer Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2-7 days approximately
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.	2-7 days approximately
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.	2-7 days approximately

Collaborators and Investigators

• Sponsor: Seer Medical Pty Ltd
• Investigators: Principal Investigator: Dean R Freestone, PhD BEng, CEO

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 17, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: HREC042_18

Drug and device information, study documents

• 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