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

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ClinicalTrials.gov Identifier: NCT03163485
Recruitment Status : Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
European Commission
University of Aarhus
Royal College of Surgeons, Ireland
Philipps University Marburg Medical Center
Dixi Medical
ARTTIC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Brain Injuries Device: Dialytrode Device: Standard treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 25, 2020
Estimated Study Completion Date : July 25, 2020


Arm Intervention/treatment
Experimental: Dialytrode
Multimodal neuro-monitoring by dialytrode (investigational medical device)
Device: Dialytrode
Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording

Standard treatment
Either EVD and/or micro-dialysis according to standard treatment
Device: Standard treatment
Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid
Other Name: EVD and/or microdialysis catheter alone




Primary Outcome Measures :
  1. Number of adverse device effects (ADE) and serious adverse device effects (SADE) [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163485


Contacts
Contact: Hajo Hamer, MD PhD +49 +9131 ext 39116 hajo.hamer@uk-erlangen.de
Contact: Felix Rosenow, MD PhD +49 +69 6301 ext 7466 rosenow@med.uni-frankfurt.de

Locations
Germany
Universitätsklinikum Erlangen Not yet recruiting
Erlangen, Germany, 91054
Contact: Hajo Hamer, Prof.Dr.med.    +49 +9131 85 ext 39116    hajo.hamer@uk-erlangen.de   
Principal Investigator: Hajo Hamer, Prof.Dr.med.         
Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main Not yet recruiting
Frankfurt am Main, Germany, 60528
Contact: Felix Rosenow, Prof.Dr.med.    +0049 +69 6301 ext 7466    rosenow@med.uni-frankfurt.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
European Commission
University of Aarhus
Royal College of Surgeons, Ireland
Philipps University Marburg Medical Center
Dixi Medical
ARTTIC
Investigators
Principal Investigator: Hajo Hamer, MD PhD Universitätsklinikum Erlangen Neurologische Klinik

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03163485     History of Changes
Other Study ID Numbers: UKER-EPIMI-RNA-C
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Erlangen-Nürnberg Medical School:
epilepsy
multimodal neuromonitoring
depth EEG
microdialysis
brain injury
brain tissue at risk
NCSE
short time monitoring
neurologic ICU

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Epilepsy
Status Epilepticus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System