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Brain device zaps seizures in Tough-to-Treat epilepsy

NCT ID NCT05147571

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a brain implant (RNS System) that delivers targeted electrical stimulation to the thalamus to reduce seizures in people aged 12 and older with drug-resistant idiopathic generalized epilepsy. The goal was to see if the device is safe and effective at cutting down generalized tonic-clonic seizures. Participants had failed at least two seizure medications before joining.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Aug 2022

Finished

Mar 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.

Ages

12 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: * Participant is age 12 and older. * Participant is male or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention). * Participant failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator. * Participant is able to maintain an electronic diary alone or with the assistance of a competent individual. * Participant is able to attend clinic appointments in accordance with the study schedule. * Participant or parent(s) or legal representative have signed an IRB approved written informed consent/assent. The informed consent form or specific assent form, where required, will be signed and dated by minors. * Participant is not currently implanted with an RNS Neurostimulator or NeuroPace Leads. * In the investigator's opinion, participant is able to tolerate a neurosurgical procedure. * Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, with or without myoclonic or absence seizures, consistent with the International League against Epilepsy Revised Classification of Seizures (2017). * Participant has had 2 or more generalized tonic-clonic seizures during the two month retrospective baseline. * Participant has had a routine electroencephalogram (EEG) within 2 years prior to enrollment with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history. * Participant has been on a stable antiseizure medication (ASM) regimen during the two month retrospective baseline and is willing to remain on a stable ASM regimen during the prospective Baseline and throughout the Effectiveness Evaluation Period, if medically possible; rescue benzodiazepine medications for acute seizure clusters are permitted. * Participant has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to enrollment that ruled out a progressive cause of epilepsy or an abnormality likely to be associated with focal-onset seizures. * Participant does not have a vagus nerve stimulator (VNS, LivaNova) or Participant's VNS is OFF during the two month retrospective baseline and participant is willing to keep the VNS off during the study. Exclusion Criteria: * Participant is pregnant. * Participant is participating in a therapeutic investigational drug or other device study. * Participant is implanted with an electronic medical device that delivers electrical energy to the brain. * Participant requires procedures that are contraindicated based on current RNS System labeling. * Participant has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Participants with post-ictal psychiatric symptoms need not be excluded. * In the opinion of the investigator, the participant has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease. * Participant has a history of partial-onset seizures or EEG findings within the past 2 years indicative of partial-onset or symptomatic generalized abnormalities. * Participant has been diagnosed with psychogenic or non-epileptic seizures in the preceding year. * Participant has experienced unprovoked status epilepticus in the preceding year. * Participant is taking any anticoagulants.

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Conditions

The condition(s) this trial relates to.

epilepsy epilepsy with generalized tonic-clonic seizures idiopathic generalized epilepsy

As listed by the trial registrant

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

Epilepsy Generalized tonic clonic seizure Idiopathic generalized epilepsy

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Mary Hitchcock Memorial Hospital (Dartmouth)

    Lebanon, New Hampshire, 03756, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55902, United States

  • New York University Langone

    New York, New York, 10016, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Spectrum Health Butterworth Hospital

    Grand Rapids, Michigan, 48503, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Utah Healthcare

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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