Subarachnoid HemorrhageNCT01802762
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
A study testing NeMo Patch and NeMo Probe in people with Subarachnoid Hemorrhage and Optical Imaging, run by NeMoDevices AG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Optical Imaging
- What is being tested?
- NeMo Patch and NeMo Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2013to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Neurointensive Care Unit, University Hospital Zurich
Zurich, 8091
About this study
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.
- Conditions
- Subarachnoid Hemorrhage, Optical Imaging
- Being tested
- NeMo Patch and NeMo Probe
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeMo Patch and NeMo ProbeDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| NeMo Patch and NeMo Probe | Other | TBI and SAH patients, one arm Receives: Device: NeMo Patch and NeMo Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 28 after removal of medical device
Secondary outcomes (1)
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
Measured: Day 28 after removal of medical device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeMoDevices AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz, University of Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802762
- Sponsor's protocol ID
- P-1.000_NeMo_C001 / MUG
- Other IDs
- E!6526_OPTO-BRAIN
- Status last verified
- Sep 2017
- First submitted
- 24 Feb 2013
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
- ClinicalTrials.gov ID
- NCT01802762
- Acronym / sponsor ID
- P-1.000_NeMo_C001 / MUG
- Conditions
- Subarachnoid Hemorrhage, Optical Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NeMoDevices AGIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz, University of Zurich
- Study start
- Jan 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeMo Patch and NeMo Probe | Other | Device: NeMo Patch and NeMo ProbeTBI and SAH patients, one arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeMo Patch and NeMo ProbeA 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) | Device | NeMo Patch and NeMo Probe |
Primary outcome
To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values.
Time frame: 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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeMo Patch and NeMo Probe in people with Subarachnoid Hemorrhage and Optical Imaging, run by NeMoDevices AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017; AzTrials last refreshed its copy on 1 Nov 2026.