Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079781
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2004-03-12
Brief Title:
RNS System Feasibility Study
Sponsor:
NeuroPace
Organization:
NeuroPace
Study Overview
Official Title:
RNS System Feasibility Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The RNS System is intended to treat patients with medically refractory hard to treat epilepsy The RNS System Feasibility study is designed to demonstrate safety and evidence of effectiveness of the RNS System to support the commencement of a pivotal clinical investigation
Detailed Description:
NeuroPace Inc is sponsoring an investigational device feasibility study of the RNS System the first closed loop responsive brain stimulator designed to treat medically refractory epilepsy The RNS System Feasibility study is a multi-center investigation being conducted at 12 epilepsy centers through the United States The first 4 subjects at each site are entered into an open label protocol and subsequent subjects at that site are entered into a randomized double-blinded sham-stimulation controlled protocol The study is designed to demonstrate safety and evidence of effectiveness of the RNS System to support commencement of a pivotal clinical investigation
The RNS Neurostimulator a pacemaker-like device and NeuroPace Leads tiny wires with electrodes are implanted in the head The Neurostimulator is a battery powered microprocessor controlled device that detects and stores records of electrographic patterns such as epileptiform or seizure-like activity from the Leads within the brain When the device detects an electrographic pattern it responds by sending electrical stimulation through the Leads to a small part of the patients brain to interrupt the electrographic pattern This type of treatment is called responsive stimulation but it is not yet known if it will work for the treatment of epilepsy Direct brain stimulation therapy has already received approval in the United States Europe Canada and Australia for the treatment of Essential Tremor and Parkinsons disease Direct brain stimulation is not approved for the treatment of epilepsy
Subjects participating in the RNS System Feasibility study are required to have successfully completed the non-significant risk Prospective Seizure Frequency PSF study which gathers baselinepre-implant seizure frequency data Subjects must also met the inclusion criteria including localization of epileptogenic regions prior to enrolling in the study Throughout the entire study subjects or their caregivers must keep a seizure diary Seizure frequency seizure severity and antiepileptic medications as well as physical and emotional health will be monitored and recorded throughout the study Antiepileptic medications should continue to remain stable until 5 months post-implant
Following enrollment and prior to RNS System implant subjects undergo a neuropsychological evaluation During the implant procedure the RNS Neurostimulator is cranially implanted and connected to one or two NeuroPace Leads implanted in the brain The investigational team determines the placement of the Leads based on prior localization of the epileptogenic region according to standard localization procedures
The Evaluation Period begins once the subject is implanted with the RNS System and continues through the 4th month Detection of epileptiform activity is enabled for all subjects within the first post-operative month Responsive stimulation is enabled and optimized for subjects enrolled in the open label protocol or randomized to the Treatment group Subjects randomized to the Sham group undergo simulated stimulation programming in order to maintain the treatment blind Randomized subjects will not know whether responsive stimulation is being delivered or not
At the beginning of the 5th month subjects transition into the Follow up Period during which all subjects may receive responsive stimulation and antiepileptic medications may be adjusted as medically required Subjects will be followed for 2 years post-implant Throughout study participation both effectiveness and safety data will be monitored continuously and reviewed and documented by the study investigator at study appointments scheduled every 1-3 months
The RNS Neurostimulator a pacemaker-like device and NeuroPace Leads tiny wires with electrodes are implanted in the head The Neurostimulator is a battery powered microprocessor controlled device that detects and stores records of electrographic patterns such as epileptiform or seizure-like activity from the Leads within the brain When the device detects an electrographic pattern it responds by sending electrical stimulation through the Leads to a small part of the patients brain to interrupt the electrographic pattern This type of treatment is called responsive stimulation but it is not yet known if it will work for the treatment of epilepsy Direct brain stimulation therapy has already received approval in the United States Europe Canada and Australia for the treatment of Essential Tremor and Parkinsons disease Direct brain stimulation is not approved for the treatment of epilepsy
Subjects participating in the RNS System Feasibility study are required to have successfully completed the non-significant risk Prospective Seizure Frequency PSF study which gathers baselinepre-implant seizure frequency data Subjects must also met the inclusion criteria including localization of epileptogenic regions prior to enrolling in the study Throughout the entire study subjects or their caregivers must keep a seizure diary Seizure frequency seizure severity and antiepileptic medications as well as physical and emotional health will be monitored and recorded throughout the study Antiepileptic medications should continue to remain stable until 5 months post-implant
Following enrollment and prior to RNS System implant subjects undergo a neuropsychological evaluation During the implant procedure the RNS Neurostimulator is cranially implanted and connected to one or two NeuroPace Leads implanted in the brain The investigational team determines the placement of the Leads based on prior localization of the epileptogenic region according to standard localization procedures
The Evaluation Period begins once the subject is implanted with the RNS System and continues through the 4th month Detection of epileptiform activity is enabled for all subjects within the first post-operative month Responsive stimulation is enabled and optimized for subjects enrolled in the open label protocol or randomized to the Treatment group Subjects randomized to the Sham group undergo simulated stimulation programming in order to maintain the treatment blind Randomized subjects will not know whether responsive stimulation is being delivered or not
At the beginning of the 5th month subjects transition into the Follow up Period during which all subjects may receive responsive stimulation and antiepileptic medications may be adjusted as medically required Subjects will be followed for 2 years post-implant Throughout study participation both effectiveness and safety data will be monitored continuously and reviewed and documented by the study investigator at study appointments scheduled every 1-3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None