RNS® System Feasibility Study

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 the RNS® System to support the commencement of a pivotal clinical investigation.

Conditions

• Epilepsy

Interventions

PROCEDURE

RNS® System implantation

Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.

DEVICE

RNS® System responsive stimulation

The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Sponsors & Collaborators

• NeuroPace

  lead INDUSTRY

Principal Investigators

• Robert Goodman, MD · Columbia University / Columbia Presbyterian Medical Center

• Gregory Barkley, MD · Henry Ford Hospital

• Greg Bergey, MD · Johns Hopkins University

• Bruce Fisch, MD · Louisiana State University Epilepsy Center of Excellence

• Robert Wharen, MD · Mayo Clinic

• Richard Marsh, MD · Mayo Clinic

• Richard Zimmerman, MD · Mayo Clinic

• Anthony Murro, MD · Augusta University

• Donna Bergen, MD · Rush University Medical Center / Epilepsy Center

• Michael Smith, MD · Rush University Medical Center / Epilepsy Center

• Ryder Gwinn, MD · Swedish Medical Center

• Douglas Labar, MD · Weill Medical College of Cornell University

• Robert Duckrow, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2006-05-31

Completion

2007-12-31

Countries

• United States

Study Locations