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New treatment option for Nervous System Diseases
Official title Functional Near-infrared Spectroscopy in Unconscious Patients
ClinicalTrials.gov ID: NCT04746820
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- experimental group:
- Patients of either sex with severe hemorrhagic, ischemic stroke or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation...
- Unconsciousness (GCS \< 9) or sedated to the severity of the disease (for the subgroup of patients included in the fNIRS-EEG measurement unconscious...
- Age ≥ 18 years
- Signed informed consent obtained from legal representative
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- Age ≥ 18 years
- Signed informed consent obtained from legal representative
- Measurement logistically and technical possible within the first 7 days after admission
- control group:
- people of either sex
- Conscious (GCS = 15)
- Age ≥ 18 years
- Signed informed consent
- 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:
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.