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Study of an External Responsive Neurostimulator System on Epileptiform Activity

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
external Responsive Neurostimulator (eRNS) System
Sponsored by
NeuroPace
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Neurostimulation

Eligibility Criteria

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

Inclusion Criteria: Subject is undergoing evaluation for epilepsy surgery in a manner consistent with the Surgery for Epilepsy, NIH Consensus Statement, 1990 Mar 19-21; 8(2); 1-20. Subject is implanted with intracranial electrodes. Subject is under constant medical supervision while implanted with the intracranial electrodes. Subject is twelve (12) years of age or older. Exclusion Criteria: Subject is pregnant. Subject has a clinically significant or unstable medical condition that, in the opinion of the investigator, would make it inadvisable for the individual to participate. Subject has a progressive central nervous system disease or serious acute or ongoing systemic illnesses. Subject has an active psychosis, severe depression, suicidal ideation or psychiatric conditions associated with impaired judgment. Subject is considered at high risk, for any reason, by any of the investigators. Subject is implanted with a medical device that might interfere with the eRNS. (This includes, but is not limited to direct brain neurostimulators, pacemakers, implantable cardiac defibrillators, spinal cord stimulators, vagal nerve stimulators, cochlear implants)

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
August 24, 2010
Sponsor
NeuroPace
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1. Study Identification

Unique Protocol Identification Number
NCT00158067
Brief Title
Study of an External Responsive Neurostimulator System on Epileptiform Activity
Official Title
Automated Response to Spontaneous Epileptiform Activity Using the External Responsive Neurostimulator (eRNS) System Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NeuroPace

4. Oversight

5. Study Description

Brief Summary
This feasibility clinical investigation is designed to demonstrate that the NeuroPace external Responsive Neurostimulator (model eRNS-300) can safely deliver responsive electrical stimulation automatically to affect epileptiform activity. The eRNS-300 is based on an implantable neurostimulator that has been adapted for acute, external use in a hospital setting.
Detailed Description
The Automated Response to Spontaneous Epileptiform Activity using the External Responsive Neurostimulator (eRNS) system clinical investigation involves subjects who are undergoing intracranial monitoring for the evaluation of epilepsy surgery and who are being monitored in the hospital's epilepsy monitoring unit. During the subject's participation, at the discretion of the investigator, the subject will be connected to the eRNS. The eRNS is an investigational device that attaches to standard intracranial electrode monitoring equipment to monitor the subject's seizure activity. It is anticipated that the subject may be connected to the eRNS for a period of time extending from one day to a few weeks. After the subject has enough seizures to complete their evaluation for epilepsy surgery, the physician may enable the responsive stimulation settings for the eRNS. The subject's participation in the clinical investigation will be complete prior to the removal of their intracranial electrodes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
external Responsive Neurostimulator (eRNS) System

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is undergoing evaluation for epilepsy surgery in a manner consistent with the Surgery for Epilepsy, NIH Consensus Statement, 1990 Mar 19-21; 8(2); 1-20. Subject is implanted with intracranial electrodes. Subject is under constant medical supervision while implanted with the intracranial electrodes. Subject is twelve (12) years of age or older. Exclusion Criteria: Subject is pregnant. Subject has a clinically significant or unstable medical condition that, in the opinion of the investigator, would make it inadvisable for the individual to participate. Subject has a progressive central nervous system disease or serious acute or ongoing systemic illnesses. Subject has an active psychosis, severe depression, suicidal ideation or psychiatric conditions associated with impaired judgment. Subject is considered at high risk, for any reason, by any of the investigators. Subject is implanted with a medical device that might interfere with the eRNS. (This includes, but is not limited to direct brain neurostimulators, pacemakers, implantable cardiac defibrillators, spinal cord stimulators, vagal nerve stimulators, cochlear implants)
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Study of an External Responsive Neurostimulator System on Epileptiform Activity

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