Functional Near-infrared Spectroscopy in Unconscious Patients

NCT04746820 | Recruiting

• 1 other identifier: 2019-02192
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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 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

Nervous System Diseases; Healthy Subjects

Keywords

severe cerebral hemorrhage; ischemic stroke; unconscious neurocritical care patients; functional near-infrared spectroscopy; evoked potentials; electroencephalography

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (1)

• Evaluation of the agreement of the results of the experimental group and the control group

  1 day

Other Outcomes (1)

• Safety endpoints (adverse events)

  7 days

Study Arms (2)

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)

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)

Other: single-center prospective pilot study

Interventions

single-center prospective pilot study OTHER

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

Control group (healthy, conscious); Experimental (unconscious)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Conscious (GCS = 15)
• Age ≥ 18 years
• Signed informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Emanuela Keller: lead

Study Sites (2)

University Hospital Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases; Cerebral Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Emanuela Keller, Prof. Dr.

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuela Keller, Prof. Dr.

CONTACT

+41 44 255 56 71; emanuela.keller@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: February 10, 2021
• Study Start: January 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)