EpilepsyNCT03163485
Hybrid Device DIALYTRODE for Multimodal Neuro-monitoring of Patients With Brain Injury and Status Epilepticus
A study testing Dialytrode and Standard treatment in people with Epilepsy and Brain Injuries, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epilepsy, Brain Injuries
- What is being tested?
- Dialytrode and Standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2019to 25 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Fragile bones of the skull
- Severe organ failure or medical conditions displaying a contraindication for participating
- Pregnant or nursing woman
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main
Frankfurt am Main, 60528
About this study
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
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.
Read the 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
- Being tested
- Dialytrode, Standard treatment
- Keywords
- epilepsy, multimodal neuromonitoring, depth EEG, microdialysis, brain injury, brain tissue at risk, NCSE, short time monitoring, neurologic ICU
- Medical subject headings
- Epilepsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DialytrodeDevice
Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording
Standard treatmentDevice
Also called EVD and/or microdialysis catheter alone
Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid
| Study group | Role | What they receive |
|---|---|---|
| Dialytrode | Experimental | Multimodal neuro-monitoring by dialytrode (investigational medical device) Receives: Device: Dialytrode |
| Standard treatment | Other | Either EVD and/or micro-dialysis according to standard treatment Receives: Device: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to day 7±2 after removal of IMD or the single control devices respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startMar 2019 (estimated)
- Primary completion25 Jun 2020 (estimated)
- Study completion25 Jul 2020 (estimated)
Why it stopped: Application to CA withdrawn due to technical reasons of the manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, University of Aarhus, Royal College of Surgeons, Ireland, Philipps University Marburg, Dixi Medical, ARTTIC
- Responsible party
- Sponsor
- Investigators
- Hajo Hamer, MD PhD, Principal investigator, Universitätsklinikum Erlangen Neurologische Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163485
- Sponsor's protocol ID
- UKER-EPIMI-RNA-C
- Status last verified
- Apr 2019
- First submitted
- 15 May 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03163485
- Acronym / sponsor ID
- UKER-EPIMI-RNA-C
- Conditions
- Epilepsy, Brain Injuries
- Keywords
- epilepsy, multimodal neuromonitoring, depth EEG, microdialysis, brain injury, brain tissue at risk, NCSE, short time monitoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Application to CA withdrawn due to technical reasons of the manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- European Commission, University of Aarhus, Royal College of Surgeons, Ireland, Philipps University Marburg, Dixi Medical, ARTTIC
- Study start
- Mar 2019 (estimated)
- Primary completion
- 25 Jun 2020 (estimated)
- Study completion
- 25 Jul 2020 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialytrode | Experimental | Device: DialytrodeMultimodal neuro-monitoring by dialytrode (investigational medical device) |
| Standard treatment | Other | Device: Standard treatmentEither EVD and/or micro-dialysis according to standard treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DialytrodeMultimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording | Device | Dialytrode |
| Standard treatmentAlso: EVD and/or microdialysis catheter aloneMonitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid | Device | Standard treatment |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hajo Hamer, MD PhD principal investigator
Universitätsklinikum Erlangen Neurologische Klinik
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialytrode and Standard treatment in people with Epilepsy and Brain Injuries, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.