RNS™ System Long-term Treatment Clinical Investigation
The RNS Long-term Treatment Clinical Investigation is designed to assess the ongoing safety and to evaluate the long-term efficacy of the Responsive Neurostimulator (RNS™) system as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Responsive Neurostimulator (RNS™) System Long-term Treatment Clinical Investigation|
- Long-term effectiveness and ongoing safety of the RNS™ System in reducing the frequency of medically uncontrolled and disabling partial onset seizures. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Device: RNS(TM) System
NeuroPace, Inc is sponsoring an investigational device study of the Responsive Neurostimulator (RNS™) system, the company's responsive brain stimulation therapy for refractory epilepsy. The RNS™ System Long-term Treatment Investigation is an open-label multi-center prospective clinical investigation. Data regarding safety and efficacy are collected at 6-month intervals, and data regarding quality of life are collected at yearly intervals. The investigation is designed to assess the ongoing safety and long-term effectiveness of the RNS™ System in reducing the frequency of medically uncontrolled and disabling partial onset seizures (those that start from one area of the brain).
The responsive neurostimulator and leads are implanted as part of the subject's participation in the RNS™ System Feasibility or Pivotal Clinical Investigations. The RNS (a pacemaker-like device) has a small battery for power and a microprocessor that detects (senses) and stores electrical activity from the brain. When the RNS detects a seizure, it responds by sending electrical stimulation through leads (tiny wires with electrodes) to a small part of the patient's brain to stop the seizure. 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 Parkinson's disease. Direct brain stimulation is not approved for the treatment of epilepsy.
To participate in the RNS™ System Long-term Treatment clinical investigation, subjects must have successfully completed participation in either the RNS™ System Feasibility or Pivotal clinical investigations.
Study participation is expected to last approximately 5 years.