Study of an External Responsive Neurostimulator System on Epileptiform Activity

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00158067

Run by

NeuroPace

People needed

150

Starts

2002-03-01

Expected to finish

2008-03-01

Last updated by the study team

2010-08-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.