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Seizure Advisory System Feasibility Study

Primary Purpose

Epilepsy

Status

Terminated

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Seizure Advisory System

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Seizures, Advisory, Prediction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Royal Melbourne Hospital
St. Vincent's Hospital (Melbourne)
Austin Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm, Device Implant

Arm Description

Outcomes

Primary Outcome Measures

The primary evaluation of safety will be an assessment of adverse events .

Secondary Outcome Measures

Seizure advisory performance will be assessed for the study population.

Clinical effectiveness will be evaluated.

Full Information

NCT ID

NCT01043406

First Posted

January 4, 2010

Last Updated

October 22, 2012

Sponsor

NeuroVista Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01043406

Brief Title

Seizure Advisory System Feasibility Study

Official Title

Safety and Effectiveness of a Seizure Advisory System in Epilepsy: A Feasibility Study (Victoria)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor restructuring.

Study Start Date

March 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroVista Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

Epilepsy, Seizures, Advisory, Prediction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm, Device Implant

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Seizure Advisory System

Intervention Description

Implant of Seizure Advisory System followed by data collection for algorithm training and subsequent enabling of seizure advisory indicators.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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) .

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Warren D Sheffield, VMD, PhD

Organizational Affiliation

NeuroVista Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

St. Vincent's Hospital (Melbourne)

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Austin Health

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

18827312

Citation

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.

Results Reference

background

PubMed Identifier

23642342

Citation

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.

Results Reference

derived

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Seizure Advisory System Feasibility Study

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