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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03882671
Registration number
NCT03882671
Ethics application status
Date submitted
11/03/2019
Date registered
20/03/2019
Date last updated
14/04/2023
Titles & IDs
Public title
Development of a Minimally Invasive Seizure Gauge
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Scientific title
Development of a Minimally Invasive Seizure Gauge
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Secondary ID [1]
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HREC042_18
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - EpiTel Epilog
Treatment: Devices - Empatica E4
Treatment: Devices - GENEActiv
Experimental: Monitoring Device - Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv
Treatment: Devices: EpiTel Epilog
EEG recording device
Treatment: Devices: Empatica E4
PPG, sweat level, temperature and accelerometry recording device
Treatment: Devices: GENEActiv
Temperature, light level and accelerometry recording device
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors
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Assessment method [1]
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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.
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Timepoint [1]
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2-7 days approximately
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Primary outcome [2]
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Wearable Sensors Comfort Assessment
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Assessment method [2]
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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.
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Timepoint [2]
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2-7 days approximately
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Primary outcome [3]
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Seizure Detection and Prediction using Multimodal Physiological Data
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Assessment method [3]
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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.
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Timepoint [3]
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2-7 days approximately
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2023
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Seer Medical - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seer Medical Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The researchers are trying to assess changes in physiological signals before and during seizures.
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Trial website
https://clinicaltrials.gov/study/NCT03882671
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dean R Freestone, PhD BEng
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Address
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CEO
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03882671
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