RNS™ System Pivotal Clinical Investigation - Full Text View

Sponsor:	NeuroPace
Information provided by (Responsible Party):	NeuroPace
ClinicalTrials.gov Identifier:	NCT00264810

Purpose

The RNS™ System Pivotal Clinical Investigation is designed to assess the safety and to demonstrate that the RNS™ System is effective as an add-on (adjunctive) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory (resistant or hard to treat) to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.

Condition	Intervention	Phase
Epilepsy	Device: Responsive Neurostimulator System	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	RNS™ System Pivotal Clinical Investigation

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by NeuroPace:

Primary Outcome Measures:

To assess the safety and to demonstrate that the Responsive Neurostimulator (RNS™) system is effective as an adjunctive therapy in reducing the frequency of seizures. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	240
Study Start Date:	November 2005
Study Completion Date:	May 2011
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Subjects will have responsive stimulation turned ON after implant with the RNS(TM) System.	Device: Responsive Neurostimulator System The RNS is a device which is implanted in the head. The RNS has a small battery for power and a microprocessor (computer chip), which detects (senses) and stores the 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 brain to try and stop seizures. Other Name: RNS(TM) System
Sham Comparator: 2 Subjects will have responsive stimulation turned OFF after implant with the RNS(TM) System. After completion of the Blinded Evaluation Period (week 20 post-implant), all subjects will have responsive stimulation enabled.	Device: Responsive Neurostimulator System The RNS is a device which is implanted in the head. The RNS has a small battery for power and a microprocessor (computer chip), which detects (senses) and stores the 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 brain to try and stop seizures. Other Name: RNS(TM) System

Arms

Assigned Interventions

Active Comparator: 1

Subjects will have responsive stimulation turned ON after implant with the RNS(TM) System.

Device: Responsive Neurostimulator System

The RNS is a device which is implanted in the head. The RNS has a small battery for power and a microprocessor (computer chip), which detects (senses) and stores the 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 brain to try and stop seizures.

Other Name: RNS(TM) System

Sham Comparator: 2

Subjects will have responsive stimulation turned OFF after implant with the RNS(TM) System. After completion of the Blinded Evaluation Period (week 20 post-implant), all subjects will have responsive stimulation enabled.

Device: Responsive Neurostimulator System

The RNS is a device which is implanted in the head. The RNS has a small battery for power and a microprocessor (computer chip), which detects (senses) and stores the 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 brain to try and stop seizures.

Other Name: RNS(TM) System

Detailed Description:

NeuroPace, Inc is sponsoring an investigational device study of the RNS™ System, the company's responsive brain stimulation therapy for refractory epilepsy. The RNS™ System Pivotal Investigation is a randomized, double-blinded, sham stimulation controlled investigation being conducted at approximately 28 sites throughout the United States. The investigation is designed to assess the safety and 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 neurostimulator and leads are implanted in the head. The RNS™ System neurostimulator (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™ System neurostimulator 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.

Study participation is expected to last approximately 2 to 3 years. All patients in the trial will be implanted with the RNS device. During the double-blind portion of the trial, half of the patients will have responsive stimulation turned ON and half will have responsive stimulation turned OFF. Patients will not know whether stimulation is being delivered or not. Five months after the RNS™ System has been implanted, when the double-blinded portion of the trial is completed, all patients will be able to have stimulation turned ON. Seizure frequency and severity, as well as physical and emotional health will be followed throughout the study.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair areas of function such as employment, psychological or social wellbeing, or mobility.
Failed treatment with a minimum of two anti-seizure medications
An average of three or more seizures every 28 days for three consecutive 28-day periods
Between the ages of 18 and 70 years.
No more than two epileptogenic regions in the brain.

Note: Patients with vagus nerve stimulators may be eligible for this clinical trial if the device has been turned off for a specified period of time and the patient agrees to have the generator explanted (excluding leads) prior to or at the time of the RNS implant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264810

Show 29 Study Locations

Sponsors and Collaborators

NeuroPace

More Information

No publications provided

Responsible Party:	NeuroPace
ClinicalTrials.gov Identifier:	NCT00264810 History of Changes
Other Study ID Numbers:	NP10004
Study First Received:	December 9, 2005
Last Updated:	January 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeuroPace:

Responsive Stimulation
Brain Stimulator
Epilepsy
Seizures

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 21, 2012