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Wireless brain implant could revolutionize epilepsy monitoring

NCT ID NCT05915988

Disease control Sponsor: UNEEG Medical A/S 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new wireless device called UNEEG EpiSight, which is implanted under the skin to record brain activity (EEG) continuously for up to 13 months. It involves 19 adults with uncontrolled epilepsy whose seizures can be detected by the implant. The goal is to see if the device works reliably and safely for long-term seizure monitoring, which could help doctors tailor treatments.

What this could mean

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

Active substance
UNEEG EpiSight device (wireless EEG implant placed under the skin)
What this could lead to
If successful, this device could provide a more convenient way to monitor seizures long-term, helping doctors better manage epilepsy.
What could go wrong
This is a small, early-stage study with only 19 participants, so results may not apply to everyone. The device requires surgery and may have risks like infection or discomfort.

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 19 people

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

Started

Dec 2023

Expected to finish

Dec 2026

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 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: * Patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant * Adults (above 18 years) * Is willing and able to use the UNEEG EpiSight solution day and night for the duration of the study * Subject is willing and able to provide written informed consent * Subject is able to complete all study-required procedures, assessments and follow-up Exclusion Criteria: * Vulnerable subjects, including severe cognitive impairment precluding informed consent * Cannot or do not have the necessary assistance, to properly operate the system * High risk of surgical complications, such as active systemic infection and haemorrhagic disease * Involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation * Contraindications to the local anaesthetic used during implantation and explantation

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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

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Beaumont Hospital

    Dublin, 9, Ireland

  • Cork University Hospital

    Cork, Ireland

  • Odense University Hospital

    Odense, 5000, Denmark

  • Regional Hospital of Viborg

    Viborg, 8800, Denmark

More trials for these conditions

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