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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Neurosurgery, Medical University of Graz, Graz, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeMo Patch and NeMo Probe

Device

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)

Primary outcomes

To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values.

Time frame: Day 28 after removal of medical device
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)

Secondary outcomes

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).

Time frame: Day 28 after removal of medical device

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

Sponsors and collaborators

Lead sponsor

NeMoDevices AG

Industry

Collaborators

Medical University of Graz
University of Zurich

Registry information

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Mar 1, 2013
Registry last updated: Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed