NCT04746820: fNIRS

Functional Near-infrared Spectroscopy in Unconscious Patients

Recruiting now NA Last updated 16 May 2025

What this trial tests

NA trial testing single-center prospective pilot study in Nervous System Diseases in 30 participants. Currently enrolling.

Timeline

15 January 2020

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Emanuela Keller
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	15 January 2020
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	2 locations across Switzerland

Drugs / interventions tested

• single-center prospective pilot study

Conditions studied

• Nervous System Diseases — all drugs for Nervous System Diseases →
• Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Emanuela Keller

Who can join

18 and older, any sex, with Nervous System Diseases or Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.