Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04746820

Functional Near-infrared Spectroscopy in Unconscious Patients

Led by Emanuela Keller · Updated on 2026-04-27

30

Participants Needed

2

Research Sites

363 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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: 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 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.

CONDITIONS

Official Title

Functional Near-infrared Spectroscopy in Unconscious Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (Glasgow Coma Scale < 9) or sedated according to disease severity; for fNIRS-EEG subgroup, defined as no response to verbal stimuli and specific motor responses to pain
  • Age 18 years or older
  • Signed informed consent from legal representative
  • Measurement possible within 7 days after admission
  • Control group: Subjects of either sex, conscious (Glasgow Coma Scale = 15), age 18 years or older, signed informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Positive pregnancy test or breastfeeding for females of childbearing potential
  • Previous auditory complaints or any ear diseases
  • No response detectable at Erb's point in somatosensory evoked potentials (e.g., due to peripheral nerve lesions or edema)
  • History of previous cerebral or brainstem disease
  • Concomitant unstable critical illness such as sepsis, multi-organ failure, or hemodynamic or respiratory instability
  • Acute status epilepticus
  • Clinical recovery (Glasgow Coma Scale 9 or higher) or death before study enrollment

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, CH-8091

Actively Recruiting

2

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, CH-8091

Actively Recruiting

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Research Team

E

Emanuela Keller, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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