Cure My Disease

Don't miss your cure!

 Log in / Sign up

Brain implant that fires at seizures tested in teens

NCT ID NCT07823465

Symptom relief 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

The NeuroPace RNS System is an implanted brain stimulator approved for adults with focal epilepsy that medicines cannot control. Researchers are gathering real-world data on how safe and effective the device is in adolescents aged 12 to 17 who already received it in routine care. The study pulls information from patient-authorized electronic health records and patient-reported outcomes across US sites, with the goal of supporting FDA approval for this age group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NeuroPace RNS System, an implanted brain stimulator that detects and interrupts seizures
What this could lead to
If the data hold up, the device could win approval for teenagers, giving younger patients with drug-resistant focal epilepsy an option beyond medication and surgery.
What could go wrong
This is a real-world data study, not a randomized trial, so the results may be less reliable than a controlled experiment. The device is already implanted, and the study cannot prove it causes any seizure reduction.
Why investors are watching

NeuroPace sells the RNS System, a brain implant that is FDA-approved for adults with drug-resistant focal epilepsy but not for adolescents. This study collects real-world safety and effectiveness data from roughly 100 adolescents aged 12 to 17 who already received the device in routine care, and NeuroPace intends the results to support expanding the approved label to that age group. For a micro-cap company with a single product, a new patient population matters because it widens the pool of people who can be treated.

If it works: If the data support the adolescent label, NeuroPace could market the RNS System to a younger patient group and add a durable source of revenue from a company that depends on one device.

If it fails: The study relies on real-world records rather than a controlled trial, so regulators may find the evidence insufficient and deny or delay the label expansion. Clinical studies often fail or fall short, and a negative result would leave the adolescent market closed.

AI-written from the trial record. Speculative, and not investment advice.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

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

Adolescents (ages 12 through 17) in the United States with drug-resistant focal epilepsy who have already been implanted with the NeuroPace RNS System (Model 320) in routine clinical practice, with implants occurring from 2018 through December 31, 2024. Patients are not drawn from a single site - they are identified from NeuroPace's commercial implant records across a variety of practice settings and geographies nationwide. Enrollment happens through OM1's Central Site regardless of where a patient was implanted or is currently treated, so the population isn't limited to sites with dedicated research infrastructure. Recruitment lists are stratified by age band (12-14 and 15-17 years) to ensure balanced representation across the full adolescent range, and only sites with at least three patients at least two years post-implant in NeuroPace's registry are eligible to contribute patients. Enrollment continues until a target of up to 100 evaluable patients is reached.

Ages

13 to 19 years

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: Aged 12-17 years at the time of first RNS neurostimulator implant Focal onset epilepsy diagnosis Implanted with the Model RNS-320 device No therapeutic surgeries performed concurrently with the RNS implant Single RNS device only at initial implant Implanted on or before December 31, 2024 Exclusion Criteria: Diagnosis of primary or symptomatic generalized epilepsy (including developmental and epileptic encephalopathies) or non-epileptic seizures Diagnosis of progressive CNS disease prior to implant Enrolled in another drug or device clinical trial at or within the first 24 months post-implant (observational studies are permitted) Episodes of status epilepticus within 3 months prior to implant

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Drug-resistant focal epilepsy are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

focal epilepsy

As listed by the trial registrant

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

Drug-resistant focal epilepsy Focal epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • OM1's Central Site (Virtual Site)

    Waltham, Massachusetts, 02451, United States

More trials for these conditions

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