Study of an External Responsive Neurostimulator System on Epileptiform Activity

This study has been completed.
Sponsor:
Information provided by:
NeuroPace
ClinicalTrials.gov Identifier:
NCT00158067
First received: September 6, 2005
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Epilepsy
Device: external Responsive Neurostimulator (eRNS) System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Automated Response to Spontaneous Epileptiform Activity Using the External Responsive Neurostimulator (eRNS) System Clinical Investigation

Resource links provided by NLM:


Further study details as provided by NeuroPace:

Estimated Enrollment: 150
Study Start Date: March 2002
Study Completion Date: March 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00158067

Locations
United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85259
United States, Georgia
Research Site
Augusta, Georgia, United States, 30912
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, New York
Research Site
New York, New York, United States, 10021
Sponsors and Collaborators
NeuroPace
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00158067     History of Changes
Other Study ID Numbers: 1006633
Study First Received: September 6, 2005
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by NeuroPace:
Epilepsy
Neurostimulation

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014