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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Optical Imaging
• Intervention / Treatment: Device: NeMo Patch and NeMo Probe

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Dept. of Neurosurgery, Medical University of Graz
• Switzerland
  • Zurich, Switzerland, 8091
    • Neurointensive Care Unit, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult male or female patient, ≥ 18 and ≤ 75 years
2. Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8)
3. Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days
4. Negative pre-treatment serum pregnancy test for female patients with childbearing potential
5. In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows

Exclusion Criteria:

1. Known kidney disease, defined as plasma creatinine > 120 µmol/l
2. Known liver disease, defined as GOT > 200U/l
3. 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
4. Pre-existing disability and/or legal representative
5. Participation in another interventional clinical trial within the last 30 days before start of treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NeMo Patch and NeMo Probe; TBI and SAH patients, one arm	Device: NeMo Patch and NeMo Probe; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NeMoDevices AG
• Collaborators: Medical University of Graz; University of Zurich

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 24, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: P-1.000_NeMo_C001 / MUG; E!6526_OPTO-BRAIN (Other Grant/Funding Number: European Union)