Status:
COMPLETED
RNS® System Feasibility Study
Lead Sponsor:
NeuroPace
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 t...
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...
Eligibility Criteria
Inclusion
- Subject has simple partial seizures (motor or sensory) or complex partial seizures (with motor manifestations) with or without secondarily generalized seizures
- Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or caregiver
- Subject has seizures that are severe enough to cause injuries or significantly impair functional ability in domains including employment, psychosocial, education and mobility
- Subject failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment
- Subject has remained on the same antiseizure medication(s) over the preceding three (3) months (independent of dose and other than acute, intermittent use of benzodiazepines)
- Subject has a minimum of four (4) or more countable seizures every month over the last three (3) months, as reported from the NeuroPace sponsored Prospective Seizure Frequency Clinical Investigation
- Subject is ≥ 18 years old and ≤ 65 years old
- Subject has undergone diagnostic testing that has established the epileptiform activity onset region(s) as part of his/her standard care to determine candidacy for epilepsy surgery
- Subject is male, or if female is using a reliable method of contraception (hormonal, barrier method, surgical or abstention), or is at least two years postmenopause
- 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 visits 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 an RNS® System
- Note: 1 month = 28 days
Exclusion
- 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
- In the opinion of the investigator, the subject has a clinically significant or unstable medical condition or a progressive central nervous system disease
- Subject has been diagnosed with active psychosis, severe depression or suicidal ideation in the preceding year
- Subject is pregnant or planning on becoming pregnant in the next year
- Subject is on the ketogenic diet
- Subject was enrolled in a therapeutic investigational drug or device study in the preceding year
- Subject has an implanted Vagus Nerve Stimulator (VNS)
- Subject has had therapeutic surgery to treat epilepsy in the preceding year
- Subject is implanted with an electronic medical device that delivers electrical energy to the head or body
- Subject is on chronic anticoagulants or, in the opinion of the investigator, subject is an unsuitable candidate for cranial surgery for any other reason
- Subject had a cranial neurosurgical procedure in the previous month
- Subject requires repeat MRIs
- Subject's seizure onset zone(s) is/are located below the level of the subthalamic nucleus or, in the opinion of the investigator, the necessary lead placement would present too high a risk
- Note: Subjects with an inactive VNS could be enrolled so long as the VNS was explanted prior to or at the same time as the RNS® System implant. Subjects who had had epilepsy surgery (resective, corpus callosotomy or ablation) greater than one year ago were still eligible.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00079781
Start Date
January 1 2004
End Date
December 1 2007
Last Update
January 29 2014
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Scottsdale
Phoenix, Arizona, United States, 85054
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
Medical College of Georgia
Augusta, Georgia, United States, 30912