Development of a Minimally Invasive Seizure Gauge

NCT03882671 | Completed FDA Device

• 1 other identifier: HREC042_18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Monitoring Device

EXPERIMENTAL

Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv

Device: EpiTel Epilog; Device: Empatica E4; Device: GENEActiv

Interventions

EpiTel Epilog DEVICE

EEG recording device

Monitoring Device

Empatica E4 DEVICE

PPG, sweat level, temperature and accelerometry recording device

Monitoring Device

GENEActiv DEVICE

Temperature, light level and accelerometry recording device

Monitoring Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.

Sponsors & Collaborators

• Seer Medical Pty Ltd: lead

Study Sites (1)

Seer Medical

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dean R Freestone, PhD BEng

  CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 20, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 15, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)