Seizure Advisory System Feasibility Study

NCT01043406 | Terminated Phase 1

• 1 other identifier: NVC1001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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.

Conditions

Epilepsy

Keywords

Epilepsy; Seizures; Advisory; Prediction

Outcome Measures

Primary Outcomes (1)

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

  Adverse events through the primary safety endpoint four months post-implant.

Secondary Outcomes (2)

• Seizure advisory performance will be assessed for the study population.

  At the primary advisory performance endpoint at the conclusion of the Data Collection Phase (approximately 3 months post-implant) .

• Clinical effectiveness will be evaluated.

  At the primary clinical effectiveness endpoint 4 months following the commencement of the Advisory Phase (approximately 7 months post-implant)

Study Arms (1)

Single Arm, Device Implant

EXPERIMENTAL

Device: Seizure Advisory System

Interventions

Seizure Advisory System DEVICE

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

Single Arm, Device Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroVista Corporation: lead

Study Sites (3)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

St. Vincent's Hospital (Melbourne)

Melbourne, Victoria, 3065, Australia

Location

Austin Health

Melbourne, Victoria, 3081, Australia

Location

Related Publications (2)

• 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.

  PMID: 18827312 BACKGROUND

• 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.

  PMID: 23642342 DERIVED

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Warren D Sheffield, VMD, PhD

  NeuroVista Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

AU (3)