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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01043406




Registration number
NCT01043406
Ethics application status
Date submitted
4/01/2010
Date registered
6/01/2010
Date last updated
24/10/2012

Titles & IDs
Public title
Seizure Advisory System Feasibility Study
Scientific title
Safety and Effectiveness of a Seizure Advisory System in Epilepsy: A Feasibility Study (Victoria)
Secondary ID [1] 0 0
NVC1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Seizure Advisory System

Experimental: Single Arm, Device Implant -


Treatment: Devices: Seizure Advisory System
Implant of Seizure Advisory System followed by data collection for algorithm training and subsequent enabling of seizure advisory indicators.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary evaluation of safety will be an assessment of adverse events .
Timepoint [1] 0 0
Adverse events through the primary safety endpoint four months post-implant.
Secondary outcome [1] 0 0
Seizure advisory performance will be assessed for the study population.
Timepoint [1] 0 0
At the primary advisory performance endpoint at the conclusion of the Data Collection Phase (approximately 3 months post-implant) .
Secondary outcome [2] 0 0
Clinical effectiveness will be evaluated.
Timepoint [2] 0 0
At the primary clinical effectiveness endpoint 4 months following the commencement of the Advisory Phase (approximately 7 months post-implant)

Eligibility
Key inclusion criteria
1. 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.
2. Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
3. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
2. 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.
3. Subject has been diagnosed with primary generalized seizures.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
St. Vincent's Hospital (Melbourne) - Melbourne
Recruitment hospital [3] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment postcode(s) [3] 0 0
3081 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NeuroVista Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this prospective, single-arm, unblinded, multicenter clinical study is to evaluate the safety and effectiveness of the NeuroVista Seizure Advisory System (SAS) in patients with medically refractory epilepsy. A total of 15 subjects will be implanted at up to three study sites.
Trial website
https://clinicaltrials.gov/study/NCT01043406
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Warren D Sheffield, VMD, PhD
Address 0 0
NeuroVista Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01043406