RNS® System Pivotal Study

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 years of age or older with partial onset seizures from no more than two foci (two areas of the brain) that are refractory (drug-resistant or hard-to-treat) to two or more antiepileptic medications. Patients continue to receive their epilepsy medications while participating in the study.

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

• Gregory Barkley, MD · Johns Hopkins University

• Michel Berg, MD · University of Rochester

• Gregory Bergey, MD · Henry Ford Hospital

• Carl Bazil, MD · Columbia University / Columbia Presbyterian Medical Center

• Andrew Cole, MD · Massachusetts General Hospital

• Michael Duchowny, MD · Nicklaus Children's Hospital f/k/a Miami Children's Hospital

• Robert Duckrow, MD · Yale University

• Jonathan Edwards, MD · Medical University of South Carolina

• Stephan Eisenschenk, MD · University of Florida at Gainesville

• A. James Fessler, MD · University of Rochester

• Nathan Fountain, MD · University of Virginia

• Eric Geller, MD · St. Barnabas Medical Center

• Robert Gross, MD · Emory University

• Ryder Gwinn, MD · Swedish Medical Center

• Christianne Heck, MD · University of Southern California

• Barbara Jobst, MD · Dartmouth-Hitchcock Medical Center

• David King-Stephens, MD · California Pacific Medical Center

• James Leiphart, MD · George Washington University

• W. Richard Marsh, MD · Mayo Clinic

• Andrew Massey, MD · Via Christi Comprehensive Epilepsy Center

• Eli Mizrahi, MD · Baylor College of Medicine

• Dileep Nair, MD · The Cleveland Clinic

• Cormac O'Donovan, MD · Wake Forest University Health Sciences

• A. LeBron Paige, MD · University of Alabama at Birmingham

• Yong Park, MD · Medical College of Georgia / Georgia Health Sciences University

• Paul Rutecki, MD · University of Wisconsin, Madison

• Vicenta Salanova, MD · Indiana University

• Christopher Skidmore, MD · Thomas Jefferson University

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

• David Spencer, MD · Oregon Health and Science University

• Paul Van Ness, MD · University of Texas Southwestern Medical Center

• Robert Wharen, MD · Mayo Clinic

• Richard Zimmerman, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2009-10-31

Completion

2011-05-31

Countries

• United States

Study Locations