Seizure Advisory System Feasibility Study

This study has been terminated.
(Sponsor restructuring.)
Sponsor:
Information provided by (Responsible Party):
NeuroVista Corporation
ClinicalTrials.gov Identifier:
NCT01043406
First received: January 4, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Epilepsy
Device: Seizure Advisory System
Phase 1

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by NeuroVista Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043406

Locations
Australia, Victoria
St. Vincent's Hospital (Melbourne)
Melbourne, Victoria, Australia, 3065
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Austin Health
Melbourne, Victoria, Australia, 3081
Sponsors and Collaborators
NeuroVista Corporation
Investigators
Study Director: Warren D Sheffield, VMD, PhD NeuroVista Corporation
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NeuroVista Corporation
ClinicalTrials.gov Identifier: NCT01043406     History of Changes
Other Study ID Numbers: NVC1001
Study First Received: January 4, 2010
Last Updated: October 22, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by NeuroVista Corporation:
Epilepsy
Seizures
Advisory
Prediction

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014