EpilepsyPhase 2NCT00158067
Study of an External Responsive Neurostimulator System on Epileptiform Activity
A Phase 2 study testing external Responsive Neurostimulator (eRNS) System in people with Epilepsy, run by NeuroPace at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- external Responsive Neurostimulator (eRNS) System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2002to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Augusta, Georgia, 30912
Research Site
Baltimore, Maryland, 21287
Research Site
New York, New York, 10021
Research Site
Rochester, Minnesota, 55905
Research Site
Scottsdale, Arizona, 85259
About this study
Official title: Automated Response to Spontaneous Epileptiform Activity Using the External Responsive Neurostimulator (eRNS) System Clinical Investigation
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- external Responsive Neurostimulator (eRNS) System
- Keywords
- Epilepsy, Neurostimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external Responsive Neurostimulator (eRNS) SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionApr 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroPace
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158067
- Sponsor's protocol ID
- 1006633
- Status last verified
- Aug 2010
- First submitted
- 6 Sep 2005
- Last updated
- 26 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Response to Spontaneous Epileptiform Activity Using the External Responsive Neurostimulator (eRNS) System Clinical Investigation
- ClinicalTrials.gov ID
- NCT00158067
- Acronym / sponsor ID
- 1006633
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Neurostimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NeuroPaceIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external Responsive Neurostimulator (eRNS) System | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing external Responsive Neurostimulator (eRNS) System in people with Epilepsy, run by NeuroPace at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2010.