search
Back to results

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

Primary Purpose

Subarachnoid Hemorrhage, Optical Imaging

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NeMo Patch and NeMo Probe
Sponsored by
NeMoDevices AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Neurosurgery, Medical University of Graz
  • Neurointensive Care Unit, University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NeMo Patch and NeMo Probe

Arm Description

TBI and SAH patients, one arm

Outcomes

Primary Outcome Measures

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)

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).
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

Full Information

First Posted
February 24, 2013
Last Updated
September 4, 2017
Sponsor
NeMoDevices AG
Collaborators
Medical University of Graz, University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT01802762
Brief Title
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
Official Title
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeMoDevices AG
Collaborators
Medical University of Graz, University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Optical Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NeMo Patch and NeMo Probe
Arm Type
Other
Arm Description
TBI and SAH patients, one arm
Intervention Type
Device
Intervention Name(s)
NeMo Patch and NeMo Probe
Intervention Description
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 Outcome Measure Information:
Title
To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values.
Description
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)
Time Frame
Day 28 after removal of medical device
Secondary Outcome Measure Information:
Title
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).
Description
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
Time Frame
Day 28 after removal of medical device

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dept. of Neurosurgery, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Neurointensive Care Unit, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.nemodevices.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs