Study of an External Responsive Neurostimulator System on Epileptiform Activity
Automated Response to Spontaneous Epileptiform Activity Using the External Responsive Neurostimulator (eRNS) System Clinical Investigation
1 other identifier
interventional
150
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2002
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedAugust 26, 2010
August 1, 2010
5.1 years
September 6, 2005
August 24, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeuroPacelead
Study Sites (5)
Research Site
Scottsdale, Arizona, 85259, United States
Research Site
Augusta, Georgia, 30912, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 12, 2005
Study Start
March 1, 2002
Primary Completion
April 1, 2007
Study Completion
March 1, 2008
Last Updated
August 26, 2010
Record last verified: 2010-08