Status:
COMPLETED
RNS® System Pivotal Study
Lead Sponsor:
NeuroPace
Conditions:
Epilepsy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 y...
Detailed Description
NeuroPace, Inc. is sponsoring an investigational device study of the RNS® System, the first closed loop responsive brain stimulator designed to treat refractory epilepsy. The RNS® System Pivotal study...
Eligibility Criteria
Inclusion
- Inclusion Criteria for enrollment:
- Subject has 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 functional ability.
- Subject's seizures are distinct, stereotypical events that can be reliably counted.
- Subject failed treatment with a minimum of 2 anti-seizure medications.
- Subject has remained on the same antiepileptic medication(s) over the 3 most recent consecutive months (other than acute, intermittent use of benzodiazepines). Subjects on the ketogenic diet are permitted if the diet has been stable for the preceding 3 months.
- Subject reports having an average of 3 or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures per month over the 3 most recent consecutive months, with no month with less than 2 seizures.
- Subject is between the ages of 18 and 70 years.
- Subject has undergone diagnostic testing that has identified no more than 2 epileptogenic regions.
- Subject is male or a female of childbearing potential using a reliable method of contraception or is at least two years post-menopause.
- Subject or legal guardian is able to provide appropriate consent to participate.
- Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.
- Subject is able to complete regular office and telephone appointments per the protocol requirements.
- Subject is willing to be implanted with the RNS® System as a treatment for his/her seizures.
- Subject is able to tolerate a neurosurgical procedure.
- Subject is considered a good candidate to be implanted with the RNS® System.
- Note: A subject is still eligible to participate if antiepileptic medication(s) were temporarily discontinued for the purposes of diagnostic or medical procedures during the preceding 3 months.
- Exclusion Criteria for enrollment:
- Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding year
- Subject has been diagnosed with primarily generalized seizures.
- Subject has experienced unprovoked status epilepticus in the preceding year.
- Subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
- Subject is taking chronic anticoagulants.
- Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded.
- Subject is pregnant or planning on becoming pregnant in the next 2 years.
- Subject is enrolled in a therapeutic investigational drug or device trial.
- Subject has an implanted Vagus Nerve Stimulator (VNS) or is unwilling to have the VNS explanted. (VNS therapy must have been discontinued for at least 3 months prior to enrollment.)
- Subject has had therapeutic surgery to treat epilepsy in the preceding 6 months.
- Subject has had a cranial neurosurgical procedure (including endovascular procedures) other than an epilepsy surgery involving the skull or brain in the previous month.
- Subject is implanted with an electronic medical device that delivers electrical energy to the head.
- Subject is an unsuitable candidate for neurosurgery.
- Subject requires repeat MRIs in which the head is exposed to the radio frequency field.
- Subject's epileptogenic region(s) is/are located caudal to the level of the thalamus.
- Implantation of the RNS® Neurostimulator and Lead(s) would present unacceptable risk.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00264810
Start Date
December 1 2005
End Date
May 1 2011
Last Update
August 28 2013
Active Locations (32)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
3
University of Southern California
Los Angeles, California, United States, 90033
4
California Pacific Medical Center
San Francisco, California, United States, 94115