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
  Purpose

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.


Condition Intervention
Subarachnoid Hemorrhage
Optical Imaging
Device: NeMo Patch and NeMo Probe

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Resource links provided by NLM:


Further study details as provided by NeMoDevices AG:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 83
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802762

Contacts
Contact: Emanuela Keller +41796025306 emanuela.keller@nemodevices.ch

Locations
Austria
Dept. of Neurosurgery, Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Gord von Campe, MD    +43-316-38581257    gord.von-campe@medunigraz.at   
Principal Investigator: Gord von Campe, MD         
Switzerland
Neurointensive Care Unit, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Emanuela Keller, MD    +41442555671    emanuela.keller@usz.ch   
Principal Investigator: Emanuela Keller, MD         
Sponsors and Collaborators
NeMoDevices AG
Medical University of Graz
University of Zurich
  More Information

Additional Information:
No publications provided

Responsible Party: NeMoDevices AG
ClinicalTrials.gov Identifier: NCT01802762     History of Changes
Other Study ID Numbers: P-1.000_NeMo_C001 / MUG, E!6526_OPTO-BRAIN
Study First Received: February 24, 2013
Last Updated: June 17, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG)
Switzerland: Swissmedic

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Injuries
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 23, 2014