Development of a Minimally Invasive Seizure Gauge

Epilepsy Clinical Trial

Official title:

Development of a Minimally Invasive Seizure Gauge

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03882671
• Other study ID #: HREC042_18
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Seer Medical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Device:
• EpiTel Epilog
EEG recording device
• Empatica E4
PPG, sweat level, temperature and accelerometry recording device
• GENEActiv
Temperature, light level and accelerometry recording device

Locations

Country	Name	City	State
Australia	Seer Medical	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Seer Medical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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