NCT03163485

Hybrid Device DIALYTRODE for Multimodal Neuro-monitoring of Patients With Brain Injury and Status Epilepticus

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Brain Injuries

Interventions

Type	Name	Description
DEVICE	Dialytrode	Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording
DEVICE	Standard treatment	Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-06-25
• Completion: 2020-07-25
• First posted: 2017-05-23
• Last updated: 2019-04-16

Locations

2 sites across 1 country: Germany