Multimodal Neuromonitoring

NCT04737369 | Unknown

• 1 other identifier: MMNM01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

1. 1.Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue.
2. 2.Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue.
3. 3.The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations
4. 4.The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome.
5. 5.Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status.

Conditions

Subarachnoid Hemorrhage; Intracerebral Hemorrhage; Traumatic Brain Injury; Cortical Spreading Depolarization and Depression; Seizures; Ictal-Interictal Continuum

Keywords

Multimodal Neuromonitoring; Electrocorticography; Cerebral Microdialysis; Neuropharmacology

Outcome Measures

Primary Outcomes (13)

• Count of SD during electrocorticography

  Count of cortical spreading depolarization (SD) during continuous electrocorticography

  up to 21 days

• Daily pattern duration of CSD during electrocorticography

  Duration of cortical spreading depression (CSD) per hour during continuous electrocorticography

  up to 21 days

• Daily pattern duration of NCSE during electrocorticography

  Duration of nonconvulsive status epilepticus (NCSE) per hour during continuous electrocorticography

  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

  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

  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

  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

  up to 21 days

• Daily duration of elevated intracranial pressure (ICP)

  Duration of elevated intracranial pressure (defined as ICP \> 22 mmHg) during continuous electrocorticography

  up to 21 days

• Neuropharmacology Cmax)

  Cmax of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)

  up to 21 days

• Neuropharmacology (AUC)

  AUC of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)

  up to 21 days

• Neuropharmacology (t1/2)

  t1/2 of routinely used sedative drug concentrations in blood and brain (Esketamine, Midazolam and Propofol)

  up to 21 days

• Neuroimaging

  Absence or presence of hypoperfusion or ischemic infarctions in neuroimaging

  up to 28 days

• Functional patient outcome

  modified Rankin Scale

  up to 6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead
• Karl Landsteiner Institute for Clinical Epilepsy Research: collaborator

Study Sites (1)

Department of Neurosurgery, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microdialysis Samples

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cerebral Hemorrhage; Brain Injuries, Traumatic; Depression; Seizures

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Johannes Herta, MD PhD

  Department of Neurosurgery, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Herta, MD PhD

CONTACT

+43 (0)1 40400-25770; johannes.herta@meduniwien.ac.at

Johannes Koren, MD PhD

CONTACT

+43 (0)1 80110-2524; johannes.koren@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Co-Head of the Neurosurgical ICU

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: February 3, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

AU (1)