Brain Injuries, Epilepsy
Conditions
Keywords
epilepsy, multimodal neuromonitoring, depth EEG, microdialysis, brain injury, brain tissue at risk, NCSE, short time monitoring, neurologic ICU
Brief summary
This clinical trial evaluates the safety and diagnostic performance of a newly developed combined catheter that will be implanted into the brain of patients with severe brain injury for short time (up to 28 days) monitoring of the electric activity and the metabolism of brain tissue at risk. Ten patients will be monitored with the new device and seven patients will be monitored by intracerebral probes according to standard treatment.
Detailed description
Early detection of nonconvulsive status epilepticus (NCSE) in patients treated in neurological intensive care unit (NICU) is essential, as delayed treatment can aggravate their clinical situation and worsen the outcome. In this study in intensive care patients with severe brain injury due to malignant middle cerebral artery (MCA) infarction, subarachnoidal hemorrhage (SAH) or intracerebral hemorrhage (ICH) with suspected status epilepticus in the surface EEG the hybrid catheter Dialytrode will be implanted in the cortical brain tissue by neurosurgeons for short time continuous bedside multimodal neuro-monitoring. Dialytrode combines a microdialysis catheter and depth EEG probe. Ten subjects will be monitored by Dialytrode and an additional (intracranial pressure (ICP) probe. Subjects with an clinical indication of an external ventricular drain (EVD) or cerebral microdialysis alone serve as control. The monitoring period with the device is limited to the microdialysis phase with a maximum of 28 days. Subjects will be followed up for 7 days after end of intracerebral monitoring.
Interventions
DEVICEDialytrode
Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording
DEVICEStandard treatment
Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid
Sponsors
European Commission
University of Aarhus
Royal College of Surgeons, Ireland
Philipps University Marburg
Dixi Medical
ARTTIC
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical condition requiring treatment in NICU 2. MCA OR Subarachnoidal haemorrhage (SAH) OR Intracerebral haemorrhage (ICH) 3. Given indication of EVD with or without multimodal monitoring by micro-dialysis OR Given indication of multimodal monitoring by micro-dialysis and continuous depth EEG-monitoring due to (a) suspected SE in surface EEG (e.g. rhythmic pattern) or (b) refractory status epilepticus (RSE) in surface EEG or (c) an unclear situation of not waking up even though sedation is reduced OR Suspected SE without acute brain injury
Exclusion criteria
(main criteria): * Subject receiving anticoagulants in therapeutic dose * Bleeding disorder * Known contraindications for EEG depth electrodes or microdialysis probes * Presence of an infectious lesion of skin (limited to the scalp) * Presence of general contraindications for any surgical intervention * Sepsis or acute severe bacterial infection * Fragile bones of the skull * Severe organ failure or medical conditions displaying a contraindication for participating * Pregnant or nursing woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse device effects (ADE) and serious adverse device effects (SADE) | Up to day 7±2 after removal of IMD or the single control devices respectively | Number of adverse device effects (ADE) and serious adverse device effects (SADE) from Baseline (day 1) to day 7+/-2 after removal of the investigational medical device (IMD) or the control devices respectively) in the intervention group compared to control |
Countries
Germany
Outcome results
None listed