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

Primary Purpose

Epilepsy, Brain Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dialytrode
Standard treatment
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring epilepsy, multimodal neuromonitoring, depth EEG, microdialysis, brain injury, brain tissue at risk, NCSE, short time monitoring, neurologic ICU

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Erlangen
  • Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dialytrode

Standard treatment

Arm Description

Multimodal neuro-monitoring by dialytrode (investigational medical device)

Either EVD and/or micro-dialysis according to standard treatment

Outcomes

Primary Outcome Measures

Number of adverse device effects (ADE) and serious adverse device effects (SADE)
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

Full Information

First Posted
May 15, 2017
Last Updated
April 12, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
European Commission, University of Aarhus, Royal College of Surgeons, Ireland, Philipps University Marburg Medical Center, Dixi Medical, ARTTIC
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1. Study Identification

Unique Protocol Identification Number
NCT03163485
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Application to CA withdrawn due to technical reasons of the manufacturer
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
June 25, 2020 (Anticipated)
Study Completion Date
July 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
European Commission, University of Aarhus, Royal College of Surgeons, Ireland, Philipps University Marburg Medical Center, Dixi Medical, ARTTIC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Brain Injuries
Keywords
epilepsy, multimodal neuromonitoring, depth EEG, microdialysis, brain injury, brain tissue at risk, NCSE, short time monitoring, neurologic ICU

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialytrode
Arm Type
Experimental
Arm Description
Multimodal neuro-monitoring by dialytrode (investigational medical device)
Arm Title
Standard treatment
Arm Type
Other
Arm Description
Either EVD and/or micro-dialysis according to standard treatment
Intervention Type
Device
Intervention Name(s)
Dialytrode
Intervention Description
Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording
Intervention Type
Device
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
EVD and/or microdialysis catheter alone
Intervention Description
Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid
Primary Outcome Measure Information:
Title
Number of adverse device effects (ADE) and serious adverse device effects (SADE)
Description
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
Time Frame
Up to day 7±2 after removal of IMD or the single control devices respectively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hajo Hamer, MD PhD
Organizational Affiliation
Universitätsklinikum Erlangen Neurologische Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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