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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by NeMoDevices AG
Sponsor:
Collaborators:
Medical University of Graz
University of Zurich
Information provided by (Responsible Party):
NeMoDevices AG
ClinicalTrials.gov Identifier:
NCT01802762
First received: February 24, 2013
Last updated: June 17, 2014
Last verified: June 2014

February 24, 2013
June 17, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values. [ Time Frame: Day 28 after removal of medical device ] [ Designated as safety issue: Yes ]

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)

Same as current
Complete list of historical versions of study NCT01802762 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Subarachnoid Hemorrhage
  • Optical Imaging
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)
NeMo Patch and NeMo Probe
TBI and SAH patients, one arm
Intervention: Device: NeMo Patch and NeMo Probe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
83
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact: Emanuela Keller +41796025306 emanuela.keller@nemodevices.ch
Austria,   Switzerland
 
NCT01802762
P-1.000_NeMo_C001 / MUG, E!6526_OPTO-BRAIN
No
NeMoDevices AG
NeMoDevices AG
  • Medical University of Graz
  • University of Zurich
Not Provided
NeMoDevices AG
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP