Status:
COMPLETED
Study of an External Responsive Neurostimulator System on Epileptiform Activity
Lead Sponsor:
NeuroPace
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 automati...
Detailed Description
The Automated Response to Spontaneous Epileptiform Activity using the External Responsive Neurostimulator (eRNS) system clinical investigation involves subjects who are undergoing intracranial monitor...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00158067
Start Date
March 1 2002
End Date
March 1 2008
Last Update
August 26 2010
Active Locations (5)
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1
Research Site
Scottsdale, Arizona, United States, 85259
2
Research Site
Augusta, Georgia, United States, 30912
3
Research Site
Baltimore, Maryland, United States, 21287
4
Research Site
Rochester, Minnesota, United States, 55905