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Development of a Minimally Invasive Seizure Gauge

Development of a Minimally Invasive Seizure Gauge

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03882671
Enrollment
40
Registered
2019-03-20
Start date
2019-01-01
Completion date
2023-12-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

EEG recording device

PPG, sweat level, temperature and accelerometry recording device

DEVICEGENEActiv

Temperature, light level and accelerometry recording device

Sponsors

Seer Medical Pty Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors2-7 days approximatelyWe 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 Assessment2-7 days approximatelyWe 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 Data2-7 days approximatelyWe 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026