New brain scanner could predict recovery in coma patients
NCT ID NCT04746820
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University Hospital Zurich
RECRUITINGZurich, Canton of Zurich, CH-8091, Switzerland
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University Hospital Zurich
RECRUITINGZurich, Canton of Zurich, CH-8091, Switzerland
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