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

Not Applicable

Completed

• Conditions: Subarachnoid Hemorrhage; Optical Imaging
• Interventions: Device: NeMo Patch and NeMo Probe

• Registration Number: NCT01802762
• Lead Sponsor: NeMoDevices AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-24
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Primary Completion: 2017-02
• Study Completion: 2017-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeMo Patch and NeMo Probe	NeMo Patch and NeMo Probe	TBI and SAH patients, one arm

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values.	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 Outcome Measures

Name	Time	Method
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).	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

Trial Locations

Locations (2)

Dept. of Neurosurgery, Medical University of Graz; 🇦🇹 Graz, Austria

Neurointensive Care Unit, University Hospital Zurich; 🇨🇭 Zurich, Switzerland