Subarachnoid HemorrhageMMNMNCT04737369
Multimodal Neuromonitoring
An observational study of Subarachnoid Hemorrhage and Intracerebral Hemorrhage, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Theoretical Framework \& Background Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Traumatic Brain Injury
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Individuals between 18-80 years with poor grade aneurysmal SAH (World Federation Neurosurgical Societies >3), severe ICH (ICH Score >3) or severe TBI (Glasgow Coma Scale <9).
Who may be able to join
- Individuals between 18-80 years with poor grade aneurysmal SAH (World Federation Neurosurgical Societies >3), severe ICH (ICH Score >3) or severe TBI (Glasgow Coma Scale < 9). The diagnosis of SAH, ICH and TBI will be established by computed tomography (CT).
- Individuals that are unlikely to regain consciousness within the following 48 hours.
- Individuals that are expected to survive for the next 48 hours.
Who cannot join
- Individuals younger than 18 years old and older than 80 years.
- Pregnant women (documented via positive ß-HCG test).
- Patients, who do not want to participate in the study. As the patient is not able to consent prior to the study, information about the study details will be given to the patient in case of clinical improvement. The patient information sheet will be handed out.
- Thereafter, the patient has the possibility to withdraw permission of study-participation.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Medical University of Vienna
Vienna, 1090
Johannes Herta, MD PhD, +43 (0)1 40400-25770, johannes.herta@meduniwien.ac.at
Johannes Koren, MD PhD, +43 (0)1 80110-2524, johannes.koren@meduniwien.ac.at
About this study
Official title: Multimodal Neuromonitoring: an Explorative Study in Neurocritical Care Patients
Theoretical Framework \& Background
Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions.
Read more
Hypotheses
- Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue.
- Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue.
- The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations
- The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome.
- Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status.
Methods
Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach.
Level of originality
Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.
- Conditions
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Traumatic Brain Injury, Cortical Spreading Depolarization and Depression, Seizures, Ictal-Interictal Continuum
- Keywords
- Multimodal Neuromonitoring, Electrocorticography, Cerebral Microdialysis, Neuropharmacology
- Medical subject headings
- Subarachnoid Hemorrhage, Cerebral Hemorrhage, Brain Injuries, Traumatic, Depression, Seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of SD during electrocorticography
Count of cortical spreading depolarization (SD) during continuous electrocorticography
Measured: up to 21 days
Daily pattern duration of CSD during electrocorticography
Duration of cortical spreading depression (CSD) per hour during continuous electrocorticography
Measured: up to 21 days
Daily pattern duration of NCSE during electrocorticography
Duration of nonconvulsive status epilepticus (NCSE) per hour during continuous electrocorticography
Measured: up to 21 days
Daily pattern duration of RPPIIC during electrocorticography
Duration of rhythmic or periodic EEG patterns on the ictal-interictal continuum (RPPIIC) per hour during continuous electrocorticography
Measured: up to 21 days
Daily duration of metabolic crisis
Duration of metabolic crisis (defined as Lactate Pyruvate ratio [LPR] > 40 and lactate higher than 4 mmol/l) during continuous electrocorticography
Measured: up to 21 days
Daily duration of mitochondrial dysfunction
Duration of mitochondrial dysfunction (defined as LPR > 40, Pyruvate > 70 μmol/l and partial brain tissue oxygenation [PbtO2] > 20 mmHg) during continuous electrocorticography
Measured: up to 21 days
Daily duration of ischemia
Duration of ischemia (defined as PbtO2 < 15 mmHg and cerebral perfusion pressure [CPP] < 60 mmHg) during continuous electrocorticography
Measured: up to 21 days
Daily duration of elevated intracranial pressure (ICP)
Duration of elevated intracranial pressure (defined as ICP > 22 mmHg) during continuous electrocorticography
Measured: up to 21 days
Neuropharmacology Cmax)
Cmax of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Measured: up to 21 days
Neuropharmacology (AUC)
AUC of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Measured: up to 21 days
Neuropharmacology (t1/2)
t1/2 of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Measured: up to 21 days
Neuroimaging
Absence or presence of hypoperfusion or ischemic infarctions in neuroimaging
Measured: up to 28 days
Functional patient outcome
modified Rankin Scale
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Karl Landsteiner Institute for Clinical Epilepsy Research
- Responsible party
- Principal investigator, Johannes Herta, Medical University of Vienna
- Investigators
- Johannes Herta, MD PhD, Principal investigator, Department of Neurosurgery, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737369
- Sponsor's protocol ID
- MMNM01
- Acronym
- MMNM
- Status last verified
- Jan 2021
- First submitted
- 9 Jun 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuromonitoring: an Explorative Study in Neurocritical Care Patients
- ClinicalTrials.gov ID
- NCT04737369
- Acronym / sponsor ID
- MMNM / MMNM01
- Conditions
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Traumatic Brain Injury, Cortical Spreading Depolarization and Depression, Seizures, Ictal-Interictal Continuum
- Keywords
- Multimodal Neuromonitoring, Electrocorticography, Cerebral Microdialysis, Neuropharmacology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Karl Landsteiner Institute for Clinical Epilepsy Research
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Feb 2021 (actual)
- 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.
Theoretical Framework \& Background
Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions.
Hypotheses
- Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue.
- Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue.
- The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations
- The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome.
- Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status.
Methods
Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach.
Level of originality
Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals between 18-80 years with poor grade aneurysmal SAH (World Federation Neurosurgical Societies >3), severe ICH (ICH Score >3) or severe TBI (Glasgow Coma Scale <9).
Key inclusion criteria (3 listed)
- Individuals between 18-80 years with poor grade aneurysmal SAH (World Federation Neurosurgical Societies >3), severe ICH (ICH Score >3) or severe TBI (Glasgow Coma Scale < 9). The diagnosis of SAH, ICH and TBI will be established by computed tomography (CT).
- Individuals that are unlikely to regain consciousness within the following 48 hours.
- Individuals that are expected to survive for the next 48 hours.
Key exclusion criteria (4 listed)
- Individuals younger than 18 years old and older than 80 years.
- Pregnant women (documented via positive ß-HCG test).
- Patients, who do not want to participate in the study. As the patient is not able to consent prior to the study, information about the study details will be given to the patient in case of clinical improvement. The patient information sheet will be handed out.
- Thereafter, the patient has the possibility to withdraw permission of study-participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Count of SD during electrocorticography
Time frame: up to 21 days
Count of cortical spreading depolarization (SD) during continuous electrocorticography
Daily pattern duration of CSD during electrocorticography
Time frame: up to 21 days
Duration of cortical spreading depression (CSD) per hour during continuous electrocorticography
Daily pattern duration of NCSE during electrocorticography
Time frame: up to 21 days
Duration of nonconvulsive status epilepticus (NCSE) per hour during continuous electrocorticography
Daily pattern duration of RPPIIC during electrocorticography
Time frame: up to 21 days
Duration of rhythmic or periodic EEG patterns on the ictal-interictal continuum (RPPIIC) per hour during continuous electrocorticography
Daily duration of metabolic crisis
Time frame: up to 21 days
Duration of metabolic crisis (defined as Lactate Pyruvate ratio [LPR] > 40 and lactate higher than 4 mmol/l) during continuous electrocorticography
Daily duration of mitochondrial dysfunction
Time frame: up to 21 days
Duration of mitochondrial dysfunction (defined as LPR > 40, Pyruvate > 70 μmol/l and partial brain tissue oxygenation [PbtO2] > 20 mmHg) during continuous electrocorticography
Daily duration of ischemia
Time frame: up to 21 days
Duration of ischemia (defined as PbtO2 < 15 mmHg and cerebral perfusion pressure [CPP] < 60 mmHg) during continuous electrocorticography
Daily duration of elevated intracranial pressure (ICP)
Time frame: up to 21 days
Duration of elevated intracranial pressure (defined as ICP > 22 mmHg) during continuous electrocorticography
Neuropharmacology Cmax)
Time frame: up to 21 days
Cmax of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Neuropharmacology (AUC)
Time frame: up to 21 days
AUC of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Neuropharmacology (t1/2)
Time frame: up to 21 days
t1/2 of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)
Neuroimaging
Time frame: up to 28 days
Absence or presence of hypoperfusion or ischemic infarctions in neuroimaging
Functional patient outcome
Time frame: up to 6 months
modified Rankin Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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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.
Johannes Herta, MD PhD principal investigator
Department of Neurosurgery, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Intracerebral Hemorrhage, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Herta, MD PhD (+43 (0)1 40400-25770, johannes.herta@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of SD during electrocorticography (time frame: up to 21 days). The study lists 13 primary outcomes in all. 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 3 Feb 2021.