- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043406
Seizure Advisory System Feasibility Study
Safety and Effectiveness of a Seizure Advisory System in Epilepsy: A Feasibility Study (Victoria)
Study Overview
Detailed Description
This research project aims to evaluate the effectiveness of the SAS based on how well it provides subjects with signals (or "advisories") that they can see and hear to predict their "likelihood" of having a seizure. It does this by monitoring signals in the brain. A secondary purpose of the study is to learn whether the advisories improve subject quality of life or that of their caregiver.
The SAS is made up of three main components that work together to monitor the subject's brain signals and then relay their information to the subject: the leads, the implantable telemetry unit (ITU), and the personal advisory device (PAD). The leads will be placed on different areas of the subject's brain to record electrical signals. The leads are tunneled down the neck to an ITU that is implanted in the chest, similar to a pacemaker. The ITU wirelessly transmits information to the PAD, which is carried like a pager. It records and processes brain signals and may be able to advise subjects when a seizure is likely or unlikely to occur.
Following implantation with the SAS, subjects will return for five study visits for neurological examinations and quality of life assessments. Throughout the study, subjects must maintain their SAS; which includes daily recharging and data card replacement.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3050
- Royal Melbourne Hospital
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Melbourne, Victoria, Australia, 3081
- Austin Health
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Melbourne, Victoria, Australia, 3065
- St. Vincent's Hospital (Melbourne)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject has disabling partial seizures and/or secondarily generalized partial seizures. Disabling refers to seizures that are severe enough to cause injuries or to significantly impair areas of function such as employment, psychological or social wellbeing, or mobility.
- Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
- For three months prior to enrollment, subject's anti-epileptic medication dosages have been stable and subject has had at least two disabling seizures per month, on average, with a seizure-free interval not to exceed 45 days. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
Exclusion Criteria:
- For three months prior to enrollment, subject's anti-epileptic medication dosages have not been stable, or subject has had more than 12 disabling seizures per month, on average, or there was a seizure-free interval longer than 45 days. Clinical seizures must be separated by a minimum of eight hours to not be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
- Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the SAS or with which the SAS interferes. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, vagus nerve stimulators (VNS), and cochlear implants. Patients with a vagus nerve stimulator implanted but turned off through the duration of the study may be enrolled, provided their clinical status has been stable for at least one month with VNS turned off.
- Subject has been diagnosed with primary generalized seizures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single Arm, Device Implant
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Implant of Seizure Advisory System followed by data collection for algorithm training and subsequent enabling of seizure advisory indicators.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary evaluation of safety will be an assessment of adverse events .
Time Frame: Adverse events through the primary safety endpoint four months post-implant.
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Adverse events through the primary safety endpoint four months post-implant.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Seizure advisory performance will be assessed for the study population.
Time Frame: At the primary advisory performance endpoint at the conclusion of the Data Collection Phase (approximately 3 months post-implant) .
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At the primary advisory performance endpoint at the conclusion of the Data Collection Phase (approximately 3 months post-implant) .
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Clinical effectiveness will be evaluated.
Time Frame: At the primary clinical effectiveness endpoint 4 months following the commencement of the Advisory Phase (approximately 7 months post-implant)
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At the primary clinical effectiveness endpoint 4 months following the commencement of the Advisory Phase (approximately 7 months post-implant)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Warren D Sheffield, VMD, PhD, NeuroVista Corporation
Publications and helpful links
General Publications
- Snyder DE, Echauz J, Grimes DB, Litt B. The statistics of a practical seizure warning system. J Neural Eng. 2008 Dec;5(4):392-401. doi: 10.1088/1741-2560/5/4/004. Epub 2008 Sep 30.
- Cook MJ, O'Brien TJ, Berkovic SF, Murphy M, Morokoff A, Fabinyi G, D'Souza W, Yerra R, Archer J, Litewka L, Hosking S, Lightfoot P, Ruedebusch V, Sheffield WD, Snyder D, Leyde K, Himes D. Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study. Lancet Neurol. 2013 Jun;12(6):563-71. doi: 10.1016/S1474-4422(13)70075-9. Epub 2013 May 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NVC1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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