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Brain surgery safety: live signal monitoring may shield speech, movement, and sight

NCT ID NCT07789938

Knowledge-focused Sponsor: Odense University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers at Odense University Hospital are testing whether monitoring brain signals during tumor surgery can help preserve functions like movement, speech, and vision. The project includes a randomized trial comparing surgery with and without motor signal monitoring, plus observational studies on language and visual signal changes. About 166 adults with brain tumors will take part. The goal is to find warning signs that let surgeons remove more tumor while avoiding permanent damage.

What this could mean

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

Active substance
Intraoperative neurophysiological monitoring (IOM), including motor evoked potentials (MEP), cortico-cortical evoked potentials (CCEP), and visual evoked potentials (VEP)
What this could lead to
If it works, this could make brain tumor surgery safer by helping surgeons avoid damaging areas that control movement, speech, and vision, potentially improving survival and quality of life.
What could go wrong
The trial is early and includes observational parts, so results may not be conclusive. Signal changes can vary between patients, and not all patients are eligible for every part.

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 166 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2029

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.

Part 1 is a litterature review. Part 2 - Inclusion Criteria: 1. Patient age ≥ 18 years and ability to provide informed consent; 2. Planned resection of ≥ 1 contrast-enhancing brain tumors (tentative diagnosis high-grade glioma or metastasis) on magnetic resonance imaging (MRI) in either general anesthesia or asleep-awake-asleep setting; 3. Intended gross total or complete tumor resection; 4. Tumor located \< 10 mm from the language areas (Broca's or Wernicke's) or subcortical language tracts (AF or SLF); 5. Tumor located in a language-dominant hemisphere; 6. Written informed consent. Part 2 - Exclusion Criteria: 1. Tumors directly involving Broca's or Wernicke's area; 2. Pregnancy; 3. Emergency surgery; 4. Tumors involving both hemispheres. Part 3 - Inclusion Criteria: 1. Patient age ≥ 18 years and ability to provide informed consent; 2. Planned resection of ≥ 1 contrast enhancing brain tumors (tentative diagnosis high-grade glioma or metastasis) on MRI in general anesthesia setting; 3. Intended gross total or complete tumor resection; 4. Tumor located \< 20 mm from the precentral gyrus or CST; 5. Written informed consent. Part 3 - Exclusion Criteria: 1. Tumors directly involving the precentral gyrus or CST; 2. Pregnancy; 3. Emergency surgery; 4. Recurrent brain tumor surgery; 5. Tumors involving both hemispheres. Part 4 - Inclusion Criteria: 1. Patient age ≥ 18 years and ability to provide informed consent; 2. Planned resection of ≥ 1 contrast enhancing pituitary tumors (tentative diagnosis adenoma), contrast enhancing brain tumors (tentative diagnosis high-grade glioma, metastasis or meningioma), or non-enhancing brain tumors (tentative diagnosis low-grade glioma) on MRI in general anesthesia setting; 3. Intended gross total or complete tumor resection; 4. Tumor located \< 10 mm from, or involving, the anterior or posterior visual pathways; 5. Written informed consent. Part 4 - Exclusion Criteria: 1. Pregnancy; 2. Emergency surgery; 3. Severe visual impairment precluding reliable VEP monitoring (typically best-corrected visual acuity ≤ 0.2-0.4 on the Snellen scale).

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Conditions

The condition(s) this trial relates to.

brain cancer low grade glioma malignant glioma meningioma metastatic malignant neoplasm in the brain pituitary gland adenoma

As listed by the trial registrant

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

Cortico-cortical evoked potential monitoring Intraoperative neurophysiological monitoring Malignant brain tumors Motor evoked potential monitoring Visual evoked potential monitoring

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

  • Department of Neurosurgery, Odense University Hospital

    Odense, Fyn, 5000, Denmark

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