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Brain implant device tracked for 5 years in epilepsy patients

NCT ID NCT02403843

Disease control Sponsor: NeuroPace Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 345 people with epilepsy who already had a brain implant called the RNS System. The goal was to see how safe and effective the device is over 5 years in everyday medical practice. Researchers measured side effects, seizure reduction, and how well doctors could use the system.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

345 people

The number who actually took part.

Started

Jun 2015

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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). This post-approval study also has the following additional study related inclusion criteria: * 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 Exclusion Criteria: 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). This post-approval study has the following additional study related exclusion criteria: * 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

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy

Contacts and locations

Locations

  • Austin Epilepsy Care Center

    Austin, Texas, 78758, United States

  • Dartmouth-Hitchcock Medical Cente

    Lebanon, New Hampshire, 03756, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Intermountain Healthcare Research

    Salt Lake City, Utah, 84157, United States

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38105, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Norton Neuroscience Institute

    Louisville, Kentucky, 40241, United States

  • Pennsylvania State University / Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Seton Family of Hospital

    Austin, Texas, 78701, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Swedish Health Services

    Seattle, Washington, 98122, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44193, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California, Irvine

    Irvine, California, 92868, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    Tampa, Florida, United States

  • University of Southern California

    Los Angeles, California, 90032, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9036, United States

  • University of Utah

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

  • University of Washington Harborview Medical Center

    Seattle, Washington, 98104, United States

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.