Study of an External Responsive Neurostimulator System on Epileptiform Activity - Full Text View

Sponsored by:	NeuroPace
Information provided by:	NeuroPace
ClinicalTrials.gov Identifier:	NCT00158067

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 II

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

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

Further study details as provided by NeuroPace:

Estimated Enrollment:	150
Study Start Date:	March 2002

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

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

Study ID Numbers:	1006633
Study First Received:	September 6, 2005
Last Updated:	June 26, 2007
ClinicalTrials.gov Identifier:	NCT00158067
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeuroPace:

Epilepsy
Neurostimulation

Study placed in the following topic categories:

Epilepsy
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on February 10, 2009