Seizure Advisory System Feasibility Study
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Effectiveness of a Seizure Advisory System in Epilepsy: A Feasibility Study (Victoria)|
- 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. ] [ Designated as safety issue: Yes ]
- 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) . ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm, Device Implant||
Device: Seizure Advisory System
Implant of Seizure Advisory System followed by data collection for algorithm training and subsequent enabling of seizure advisory indicators.
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.
|St. Vincent's Hospital (Melbourne)|
|Melbourne, Victoria, Australia, 3065|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Melbourne, Victoria, Australia, 3081|
|Study Director:||Warren D Sheffield, VMD, PhD||NeuroVista Corporation|