RNS® System Epilepsy Post-Approval Study

NCT02403843 | Completed DMC

• 2 other identifiers: NP10012PMA100026
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 35

Brief Summary

The purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (7)

• SAE rate

  Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.

  Implant through 5 years post-implant

• Neurosurgeon experience

  Demonstrate there is no difference in safety in 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.

  Implant through 41 days post-implant

• Physician experience

  Demonstrate there is no difference in safety 1 year post-implant based on experience of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.

  Implant through 1 year post-implant

• Product use - surgical procedures

  Present the incidence and number of AEs related to surgical procedures associated with implant, explant, reimplantation, and revision of the neurostimulator and lead(s).

• Autopsy

  Present data from autopsies obtained from any patient implanted with neurostimulator/leads.

• Median percentage reduction in disabling seizure

  Demonstrate that the median percentage reduction in disabling seizures over time in the entire subject population is comparable to the median percentage reduction in disabling seizures over time in the LTT study. Characterize the median percentage reduction in disabling seizures over time within subpopulations.

  Pre-implant (retrospective data) compared to 30 to 36 months post-implant

• Neurostimulator programming

  Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.

  Through 5 years post-implant

Secondary Outcomes (2)

• Seizure worsening

  6 months post-implant through 36 months post-implant

• Neurostimulator programming

  Implant through 5 years post-implant

Other Outcomes (1)

• Neurostimulator battery longevity

Study Arms (1)

Evaluation

A group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term.

Device: RNS System

Interventions

RNS System DEVICE

The RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures.

You may qualify if:

• A clinical decision to treat the patient with the RNS System in accordance with its approved indication for use has been made prior to enrollment in the study. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
• Subject or legal guardian is able to provide appropriate consent to participate
• Subject is able to maintain a seizure diary alone or with the assistance of a competent individual
• Subject is able to attend clinic appointments in accordance with the study schedule

You may not qualify if:

• Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
• Subject is participating in a therapeutic investigational drug or device study
• Subject was treated with a VNS within the last three months (90 days)
• Subject is pregnant

Sponsors & Collaborators

• NeuroPace: lead

Study Sites (35)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, Irvine

Irvine, California, 92868, United States

Location

University of Southern California

Los Angeles, California, 90032, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Norton Neuroscience Institute

Louisville, Kentucky, 40241, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock Medical Cente

Lebanon, New Hampshire, 03756, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44193, United States

Location

Pennsylvania State University / Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Seton Family of Hospital

Austin, Texas, 78701, United States

Location

Austin Epilepsy Care Center

Austin, Texas, 78758, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9036, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Location

University of Utah

Salt Lake City, Utah, 84132-5901, United States

Location

Intermountain Healthcare Research

Salt Lake City, Utah, 84157, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• Bergey GK, Morrell MJ, Mizrahi EM, Goldman A, King-Stephens D, Nair D, Srinivasan S, Jobst B, Gross RE, Shields DC, Barkley G, Salanova V, Olejniczak P, Cole A, Cash SS, Noe K, Wharen R, Worrell G, Murro AM, Edwards J, Duchowny M, Spencer D, Smith M, Geller E, Gwinn R, Skidmore C, Eisenschenk S, Berg M, Heck C, Van Ness P, Fountain N, Rutecki P, Massey A, O'Donovan C, Labar D, Duckrow RB, Hirsch LJ, Courtney T, Sun FT, Seale CG. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. 2015 Feb 24;84(8):810-7. doi: 10.1212/WNL.0000000000001280. Epub 2015 Jan 23.

  PMID: 25616485 BACKGROUND

• Heck CN, King-Stephens D, Massey AD, Nair DR, Jobst BC, Barkley GL, Salanova V, Cole AJ, Smith MC, Gwinn RP, Skidmore C, Van Ness PC, Bergey GK, Park YD, Miller I, Geller E, Rutecki PA, Zimmerman R, Spencer DC, Goldman A, Edwards JC, Leiphart JW, Wharen RE, Fessler J, Fountain NB, Worrell GA, Gross RE, Eisenschenk S, Duckrow RB, Hirsch LJ, Bazil C, O'Donovan CA, Sun FT, Courtney TA, Seale CG, Morrell MJ. Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia. 2014 Mar;55(3):432-41. doi: 10.1111/epi.12534. Epub 2014 Feb 22.

  PMID: 24621228 BACKGROUND

• Morrell MJ; RNS System in Epilepsy Study Group. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 2011 Sep 27;77(13):1295-304. doi: 10.1212/WNL.0b013e3182302056. Epub 2011 Sep 14.

  PMID: 21917777 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Martha J Morrell, MD

  NeuroPace, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)