Nervous System DiseasesfNIRSNCT04746820
Functional Near-infrared Spectroscopy in Unconscious Patients
A study testing single-center prospective pilot study in people with Nervous System Diseases and Healthy Subjects, run by Emanuela Keller at 1 site in Switzerland.
Trial summary
The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases, Healthy Subjects
- What is being tested?
- single-center prospective pilot study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2020to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Subjects of either sex
Show all 9Show fewer
- Conscious (GCS = 15)
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- 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)
Show all 13Show fewer
- Acute status epilepticus
- Clinical recovery (GCS ≥ 9) or death before enrolment of the study
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study
The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients.
In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG).
Read more
The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation.
fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects.
To compare fNIRS with evoked potentials there are two test phases:
- The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP
- The cerebral response to an auditory stimulus is measured by fNIRS and AEP
To avoid biases the following has to be considered:
- The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously.
- If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.
Read the detailed description
Severe ischemic and hemorrhagic stroke, as well cardiac arrest even after successful cardiopulmonary reanimation are great causes of morbidity and mortality in Europe and worldwide. Although prevention and therapy strategies, have been successfully improved during the past decades, the global stroke burden - measured in disability adjusted life years (DALY) - is still great.
Specifically, the improvements of intensive care treatments and neurosurgical procedures have lowered mortality rates, but simultaneously have increased survivors with severe disorder of consciousness (DoC) or persistent disabilities. As a result, an early prognosis in unconscious patients suffering from severe stroke in the intensive care unit (ICU) becomes more important for the clinician. An early reliable prognosis enables the clinician to empower the surrogates of an unconscious patient to make choices consistent with his preferences. It improves also overall patient management in the NICU and helps to identify an appropriate rehabilitation care. Since clinical assessment of comatose Patients is limited, other examinations are needed to enhance the reliability of a prognosis.
Evoked potentials, especially somatosensory and auditory evoked potentials (SSEP and AEP) are well established prognostic tools in unconscious ICU patients.
The advantage of evoked potentials over clinical assessments such as the Glasgow coma score (GCS) or laboratory values are that they are not influenced by intensive care interventions, and have a higher interrater reliability. They are also resistant to metabolic changes or sedation.
Electroencephalography (EEG) is another established prognostic tool in comatose patients. However, both, evoked potential and EEG are highly vulnerable to artefacts and expensive due to high workforce requirements.
Functional near-infrared spectroscopy (fNIRS) is a promising strictly non-invasive, bedside examination. It is based on the finding that infrared light is absorbed by oxygenated and deoxygenated haemoglobin. Brain activation can be measured with fNIRS due to an increase of oxygenated haemoglobin and decrease of deoxygenated haemoglobin. Different studies show that brain activation as a response to peripheral somatosensory and auditory stimulation as it is conducted in SSEP and AEP can be detected by fNIRS. Recent studies investigated also the use of fNIRS in unconscious patients. However, it is unknown whether and how the brain activation measured by fNIRS due to sensory stimulation correlates to the measurements of evoked potentials in unconscious patients and if it has any prognostic value in unconscious patients.
Therefore, the investigator aims to compare fNIRS with SSEP and AEP in unconscious neuro-intensive care patients suffering from severe hemorrhagic or ischemic stroke and in a control group with healthy conscious subjects. Hence, making it a potential prognostic tool for unconscious ICU patients.
- Conditions
- Nervous System Diseases, Healthy Subjects
- Being tested
- single-center prospective pilot study
- Keywords
- severe cerebral hemorrhage, ischemic stroke, unconscious neurocritical care patients, functional near-infrared spectroscopy, evoked potentials, electroencephalography
- Medical subject headings
- Nervous System Diseases, Cerebral Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-center prospective pilot studyOther
fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects.
To compare fNIRS with evoked potentials there are two test phases:
- The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP
- The cerebral response to an auditory stimulus is measured by fNIRS and AEP
| Study group | Role | What they receive |
|---|---|---|
| Experimental (unconscious) | Experimental | fNIRS will be compared to evoked potentials in an experimental group (unconscious neuro-intensive care patients) and in a control group (healthy, conscious subjects) Receives: Other: single-center prospective pilot study |
| Control group (healthy, conscious) | Sham comparator | fNIRS will be compared to evoked potentials in an experimental group (unconscious neuro-intensive care patients) and in a control group (healthy, conscious subjects) Receives: Other: single-center prospective pilot study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of fNIRS examination to those of evoked potentials (presence or absence of response) in unconscious ICU patients with severe hemorrhagic, ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation.
Correlation of presence of typical relative changes in NIRS pattern (increase of oxygenated hemoglobin and decrease of deoxygenated haemoglobin) to positive response to somatosensory and auditory stimulation measured by electroencephalography (change of cortical electrical acivity after stimulation). Both signals will be either present or absent.
Measured: 7 days
Secondary outcomes (1)
Evaluation of the agreement of the results of the experimental group and the control group
Frequency of presence of typical relative changes in NIRS pattern (increase of oxygenated hemoglobin and decrease of deoxygenated haemoglobin) compared in healthy controls and patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start15 Jan 2020
- Primary completion14 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. 1. Experimental group: All included patients will be examined with fNIRS, sSEP and AEP examination within 7 days after admission. fNIRS, SSEP and AEP examination. 2. Control group: The control group will be recruited among employees of the University Hospital Zurich, which are not subordinate to the PI and will have the same examinations as the experimental group.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuela Keller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emanuela Keller, University of Zurich
- Investigators
- Emanuela Keller, Prof. Dr., Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746820
- Sponsor's protocol ID
- 2019-02192
- Other IDs
- 2019
- Acronym
- fNIRS
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04746820
- Acronym / sponsor ID
- fNIRS / 2019-02192
- Conditions
- Nervous System Diseases, Healthy Subjects
- Keywords
- severe cerebral hemorrhage, ischemic stroke, unconscious neurocritical care patients, functional near-infrared spectroscopy, evoked potentials, electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emanuela KellerUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients.
In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG).
The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation.
fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects.
To compare fNIRS with evoked potentials there are two test phases:
- The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP
- The cerebral response to an auditory stimulus is measured by fNIRS and AEP
To avoid biases the following has to be considered:
- The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously.
- If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.
Detailed description
Severe ischemic and hemorrhagic stroke, as well cardiac arrest even after successful cardiopulmonary reanimation are great causes of morbidity and mortality in Europe and worldwide. Although prevention and therapy strategies, have been successfully improved during the past decades, the global stroke burden - measured in disability adjusted life years (DALY) - is still great.
Specifically, the improvements of intensive care treatments and neurosurgical procedures have lowered mortality rates, but simultaneously have increased survivors with severe disorder of consciousness (DoC) or persistent disabilities. As a result, an early prognosis in unconscious patients suffering from severe stroke in the intensive care unit (ICU) becomes more important for the clinician. An early reliable prognosis enables the clinician to empower the surrogates of an unconscious patient to make choices consistent with his preferences. It improves also overall patient management in the NICU and helps to identify an appropriate rehabilitation care. Since clinical assessment of comatose Patients is limited, other examinations are needed to enhance the reliability of a prognosis.
Evoked potentials, especially somatosensory and auditory evoked potentials (SSEP and AEP) are well established prognostic tools in unconscious ICU patients.
The advantage of evoked potentials over clinical assessments such as the Glasgow coma score (GCS) or laboratory values are that they are not influenced by intensive care interventions, and have a higher interrater reliability. They are also resistant to metabolic changes or sedation.
Electroencephalography (EEG) is another established prognostic tool in comatose patients. However, both, evoked potential and EEG are highly vulnerable to artefacts and expensive due to high workforce requirements.
Functional near-infrared spectroscopy (fNIRS) is a promising strictly non-invasive, bedside examination. It is based on the finding that infrared light is absorbed by oxygenated and deoxygenated haemoglobin. Brain activation can be measured with fNIRS due to an increase of oxygenated haemoglobin and decrease of deoxygenated haemoglobin. Different studies show that brain activation as a response to peripheral somatosensory and auditory stimulation as it is conducted in SSEP and AEP can be detected by fNIRS. Recent studies investigated also the use of fNIRS in unconscious patients. However, it is unknown whether and how the brain activation measured by fNIRS due to sensory stimulation correlates to the measurements of evoked potentials in unconscious patients and if it has any prognostic value in unconscious patients.
Therefore, the investigator aims to compare fNIRS with SSEP and AEP in unconscious neuro-intensive care patients suffering from severe hemorrhagic or ischemic stroke and in a control group with healthy conscious subjects. Hence, making it a potential prognostic tool for unconscious ICU patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. 1. Experimental group: All included patients will be examined with fNIRS, sSEP and AEP examination within 7 days after admission. fNIRS, SSEP and AEP examination. 2. Control group: The control group will be recruited among employees of the University Hospital Zurich, which are not subordinate to the PI and will have the same examinations as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Experimental (unconscious) | Experimental | Other: single-center prospective pilot studyfNIRS will be compared to evoked potentials in an experimental group (unconscious neuro-intensive care patients) and in a control group (healthy, conscious subjects) |
| Control group (healthy, conscious) | Sham comparator | Other: single-center prospective pilot studyfNIRS will be compared to evoked potentials in an experimental group (unconscious neuro-intensive care patients) and in a control group (healthy, conscious subjects) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-center prospective pilot studyfNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP | Other | Control group (healthy, conscious), Experimental (unconscious) |
Primary outcome
Results of fNIRS examination to those of evoked potentials (presence or absence of response) in unconscious ICU patients with severe hemorrhagic, ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation.
Time frame: 7 days
Correlation of presence of typical relative changes in NIRS pattern (increase of oxygenated hemoglobin and decrease of deoxygenated haemoglobin) to positive response to somatosensory and auditory stimulation measured by electroencephalography (change of cortical electrical acivity after stimulation). Both signals will be either present or absent.
1 secondary outcome
Evaluation of the agreement of the results of the experimental group and the control group
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuela Keller, Prof. Dr. principal investigator
University Hospital, Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-center prospective pilot study in people with Nervous System Diseases and Healthy Subjects, run by Emanuela Keller at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of fNIRS examination to those of evoked potentials (presence or absence of response) in unconscious ICU patients with severe hemorrhagic, ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.