Seizure Advisory System Feasibility Study
|ClinicalTrials.gov Identifier: NCT01043406|
Recruitment Status : Terminated (Sponsor restructuring.)
First Posted : January 6, 2010
Last Update Posted : October 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Device: Seizure Advisory System||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness of a Seizure Advisory System in Epilepsy: A Feasibility Study (Victoria)|
|Study Start Date :||March 2010|
|Primary Completion Date :||August 2012|
|Study Completion Date :||October 2012|
|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.
- 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. ]
- 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) . ]
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043406
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|St. Vincent's Hospital (Melbourne)|
|Melbourne, Victoria, Australia, 3065|
|Melbourne, Victoria, Australia, 3081|
|Study Director:||Warren D Sheffield, VMD, PhD||NeuroVista Corporation|