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

NCT03163485 | Withdrawn

• 1 other identifier: UKER-EPIMI-RNA-C
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Brain Injuries

Keywords

epilepsy; multimodal neuromonitoring; depth EEG; microdialysis; brain injury; brain tissue at risk; NCSE; short time monitoring; neurologic ICU

Outcome Measures

Primary Outcomes (1)

• 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

  Up to day 7±2 after removal of IMD or the single control devices respectively

Study Arms (2)

Dialytrode

EXPERIMENTAL

Multimodal neuro-monitoring by dialytrode (investigational medical device)

Device: Dialytrode

Standard treatment

OTHER

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

Device: Standard treatment

Interventions

Dialytrode DEVICE

Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording

Dialytrode

Standard treatment DEVICE

Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid

Also known as: EVD and/or microdialysis catheter alone

Standard treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• European Commission: collaborator
• University of Aarhus: collaborator
• Royal College of Surgeons, Ireland: collaborator
• Philipps University Marburg: collaborator
• Dixi Medical: collaborator
• ARTTIC: collaborator

Study Sites (2)

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Frankfurt Epilepsiezentrum Rhein-Main

Frankfurt am Main, 60528, Germany

Location

MeSH Terms

Conditions

Epilepsy; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Hajo Hamer, MD PhD

  Universitätsklinikum Erlangen Neurologische Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 23, 2017
• Study Start: March 1, 2019
• Primary Completion: June 25, 2020
• Study Completion: July 25, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

DE (2)