RNS® System Feasibility Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00079781

Run by

NeuroPace

People needed

70

Starts

2004-01-01

Expected to finish

2007-12-01

Last updated by the study team

2014-01-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Scottsdale — Phoenix, Arizona, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Rush University Medical Center / Epilepsy Center — Chicago, Illinois, United States
• Louisiana State University Epilepsy Center of Excellence — New Orleans, Louisiana, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Columbia University / Columbia Presbyterian Medical Center — New York, New York, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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