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New device tweak could make brain surgery safer

NCT ID NCT06480370

Knowledge-focused Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests different ways to stimulate the brain during surgery to monitor motor function while minimizing patient movement. Researchers will use accelerometers and microscope video to measure movement. The goal is to make brain surgery safer by protecting areas that control movement.

What this could mean

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

Active substance
ISIS IOM System (device for electrical stimulation and monitoring)
What this could lead to
If successful, this could lead to safer brain surgeries by reducing unintended patient movement and better protecting motor function.
What could go wrong
This is an early-stage optimization study, not a treatment trial. Results may not change standard practice or benefit all patients.

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 203 people

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

Started

Feb 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Informed consent signed by the subject * The patient has a supra-tentorial lesion requiring surgery * The patient is undergoing neurosurgery with the use of MEP monitoring during surgery to protect functional tissue\* (During routine preparation for the surgery, patients are checked for any relative contraindications as listed in the user manual of the ISIS IOM System (see p. 11, chapter 2.2.4 of the user manual). Every relative contraindication must be weighed against the risk and benefits of the measurement signals which are routinely needed for the surgical intervention. There are no absolute contraindications for the ISIS IOM System.) * The patient is older than 18 years Exclusion Criteria: * No need for MEP monitoring * Vulnerable subjects (pregnant, impaired consciousness) * People who do not want to participate in the study * Emergency procedures in which no consent was obtained before the operation * Multiple surgeries on the same patient * Preoperative non-affected arm or leg motor deficit (MRC \<5), that is to say, no motor deficit of the arm or leg ipsilateral to the surgery * Inhalational anesthesia * Persisting neuromuscular blockade * Impossibility to place the stimulating or recording electrodes in the appropriate site

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As listed by the trial registrant

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

Surgery

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

  • Dep. of Neurosurgery, Bern University Hospital

    RECRUITING

    Bern, 3010, Switzerland

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