Clinical trial NCT03163485: Hybrid Device DIALYTRODE for Multimodal Neuro-monitoring of Patients With Brain Injury and Status Epilepticus
Official title: Prospective, Open Label, Multi-centre, Controlled Phase 2a Clinical Trial to Investigate the Safety and Diagnostic Performance of the Multifunctional Hybrid Device Combining a Micro-dialysis Probe With an Intra-cortical Depth Electrode (DIALYTRODE) for Short Time Continuous Multimodal Neuro-monitoring of NICU Patients With Severe Brain Injury and Suspected Status Epilepticus in Surface EEG
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Brain Injuries
Keywords: epilepsy
multimodal neuromonitoring
depth EEG
microdialysis
brain injury
brain tissue at risk
NCSE
short time monitoring
neurologic ICU
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: European Commission
name: University of Aarhus
name: Royal College of Surgeons, Ireland
name: Philipps University Marburg
name: Dixi Medical
name: ARTTIC
First posted: 2017-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse device effects (ADE) and serious adverse device effects (SADE)
timeFrame: Up to day 7±2 after removal of IMD or the single control devices respectively
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main
Study officials:
affiliation: Universitätsklinikum Erlangen Neurologische Klinik
name: Hajo Hamer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: