Hybrid Device DIALYTRODE for Multimodal Neuro-monitoring of Patients With Brain Injury and Status Epilepticus
- Conditions
- Brain InjuriesEpilepsy
- Interventions
- Device: DialytrodeDevice: Standard treatment
- Registration Number
- NCT03163485
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Clinical condition requiring treatment in NICU
- MCA OR Subarachnoidal haemorrhage (SAH) OR Intracerebral haemorrhage (ICH)
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dialytrode Dialytrode Multimodal neuro-monitoring by dialytrode (investigational medical device) Standard treatment Standard treatment Either EVD and/or micro-dialysis according to standard treatment
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main
🇩🇪Frankfurt am Main, Germany