A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Study Overview
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Brief Summary
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To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.

Official Title
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A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Conditions
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Subarachnoid Hemorrhage, Optical Imaging

Intervention / Treatment
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* Device: NeMo Patch and NeMo Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female patient, ≥ 18 and ≤ 75 years Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8) Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days Negative pre-treatment serum pregnancy test for female patients with childbearing potential In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows Exclusion Criteria: Known kidney disease, defined as plasma creatinine > 120 µmol/l Known liver disease, defined as GOT > 200U/l History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism Pre-existing disability and/or legal representative Participation in another interventional clinical trial within the last 30 days before start of treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NeMo Patch and NeMo Probe<br>TBI and SAH patients, one arm | Device: NeMo Patch and NeMo Probe<br>* A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values. | Feasibility: User acceptance: For NeMo Probes in comparison to conventional probes for intracranial pressure (ICP-) monitoring; for NeMo Patch in comparison to patches for electroencephalography (EEG) monitoring. Detailled evaluation of user acceptance: Incidence of concerns of users in relation to the installation, function and removal of the NeMo System (= NeMo Probe, NeMo Patch, NeMo Control Unit and NeMo Software pre-installed on a Medical PC) User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional devices Accuracy of measurements: -Patients: Results from repeated measurements of mean transit time of ICG (mttICG), cerebral blood flow (CBF) and cerebral blood volume (CBV) Safety parameters: Incidence of complications (infections, brain tissue damage, haemorrhage) compared to historical series (patches for EEG and for BIS measurements; conventional probes for ICP monitoring) | Day 28 after removal of medical device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the ability of the neuromonitoring system to detect secondary ischemic events in patients with severe subarachnoid haemorrhage (SAH) or severe traumatic brain injury (TBI). | Results concerning sensitivity and specificity to detect symptomatic vasospasm in patients with subarachnoid hemorrhage (SAH) (correlation of events with CBF values < 15 ml/100g/min with defined criteria for vasospasm) Results concerning sensitivity and specificity to detect secondary infarctions and critical ICP values in TBI patients (correlation of events with CBF values < 15 ml/100g/min with defined criteria for secondary infarction) Results from repeated measurements for the difference between measurement values obtained with the NeMo Patch and the NeMo Probe, quantified with mathematical models | Day 28 after removal of medical device |