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Implantable brain device aims to tame Drug-Resistant seizures

NCT ID NCT07301346

Disease control Sponsor: Precisis US, Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests a device called EASEE® that is implanted under the skin and above the skull to stimulate the brain and reduce seizures in people with drug-resistant focal epilepsy. Two hundred adults will receive the implant, and half will have the stimulation turned on for 6 months to compare seizure reduction. The goal is to see if the device is safe and effective over 18 months.

What this could mean

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

Active substance
implantable brain stimulator (EASEE® System)
What this could lead to
If it works, this could offer a new, minimally invasive option to reduce seizures in people with epilepsy that doesn't respond to medication.
What could go wrong
This is an early pivotal study with 200 participants, so results may not apply to everyone. Risks include surgical complications and the device may not reduce seizures for all.

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

About 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

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.

Ages

18 to 75 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: * Adult between 18-75 years of age * Diagnosis of drug-resistant focal epilepsy * At least four (4) observable seizure manifestations per month * Stable anti-seizure medication regimen Exclusion Criteria: * Diagnostic of non-epileptic seizures * Active idiopathic generalized epilepsy * Recent status epileptics (\<12 months) * Clinically significant or unstable medical condition * Active psychosis, major depression, suicidal ideation (\<6 months) * Pregnancy * Implanted with brain stimulation device or active Vagus Nerve Stimulation

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Conditions

The condition(s) this trial relates to.

epilepsy focal epilepsy

As listed by the trial registrant

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

Drug-resistant 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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Columbia University Irving Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

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