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Clinical Trials/NCT03882671
NCT03882671
Completed
Not Applicable

Development of a Minimally Invasive Seizure Gauge

Seer Medical Pty Ltd1 site in 1 country40 target enrollmentJanuary 1, 2019
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Seer Medical Pty Ltd
Enrollment
40
Locations
1
Primary Endpoint
Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2023
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Seer Medical Pty Ltd
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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