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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03465189
Registration number
NCT03465189
Ethics application status
Date submitted
7/03/2018
Date registered
14/03/2018
Date last updated
27/10/2020
Titles & IDs
Public title
Validation of a Seizure Monitoring System
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Scientific title
Validation of a Seizure Monitoring System
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Secondary ID [1]
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HREC/18/SVHM/50
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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
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Medtronic LINQ Device
Treatment: Devices: Medtronic LINQ Device
Using two LINQ devices that are fixed to scalp to record EEG (in addition to the standard scalp EEG).
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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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Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management
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Assessment method [1]
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Compare EEG from traditional scalp EEG to the LINQ recordings to determine if seizure activity can be accurately identified
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Timepoint [1]
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one week
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Eligibility
Key inclusion criteria
- Patients with epilepsy
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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
- Women that are pregnant
- Patients that are highly dependant on medical care
- Patients that cannot give informed consent for themselves
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
10/09/2018
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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
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Actual
19/03/2020
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincent's Hospital Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
St Vincent's Hospital Melbourne
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University of Melbourne
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Seer Medical
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The investigators aim to determine the feasibility of using the Medtronic LINQ device for
epilepsy diagnosis, monitoring and management. The feasibility will be determined by
comparing EEG signals from the LINQ system to the gold standard clinical recordings. If
seizures can be identified using the LINQ device with the same level of accuracy as adjacent
scalp EEG recording electrodes, then the LINQ will be deemed feasible.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03465189
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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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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 public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03465189
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