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New brain scanner could predict recovery in coma patients

NCT ID NCT04746820

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new brain scanning method called fNIRS to see if it can predict recovery in unconscious ICU patients with severe stroke or brain injury. Researchers will compare fNIRS results with standard tests in 30 patients and healthy volunteers. If successful, fNIRS could become a simple, bedside tool to help doctors understand brain function and guide care.

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 30 people

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

Started

Jan 2020

Expected to finish

Dec 2026

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

Accepted

You do not need to have the condition being studied to take part.

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 - experimental group: * Patients of either sex with severe hemorrhagic, ischemic stroke or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation treated at the Institute of Intensive Care Medicine, University Hospital Zurich * Unconsciousness (GCS \< 9) or sedated to the severity of the disease (for the subgroup of patients included in the fNIRS-EEG measurement unconscious patients are defined as not responding to verbal stimuli. The motor response to pain should be one of the following: no response to pain / extensor response / flexor response / localize to pain) * Age ≥ 18 years * Signed informed consent obtained from legal representative * Measurement logistically and technical possible within the first 7 days after admission Inclusion Criteria - control group: * Subjects of either sex * Conscious (GCS = 15) * Age ≥ 18 years * Signed informed consent Exclusion Criteria - experimental group: * Patients age \< 18 years * Positive pregnancy test for any female of childbearing potential or breast feeding female * Previous auditory complaints or any ear diseases * No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.) * Any history of previous cerebral or brainstem disease * Concomitant instable critical illness (e.g. sepsis, multi-organ failure, hemodynamic or respiratory instability) * Acute status epilepticus * Clinical recovery (GCS ≥ 9) or death before enrolment of the study Exclusion Criteria - control group: * Subjects age \< 18 years * Positive pregnancy test for any female of childbearing potential or breast feeding female * Previous auditory complaints or any ear diseases * No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.) * Any history of previous cerebral or brainstem disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • University Hospital Zurich

    RECRUITING

    Zurich, Canton of Zurich, CH-8091, Switzerland

  • University Hospital Zurich

    RECRUITING

    Zurich, Canton of Zurich, CH-8091, Switzerland

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