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

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

Interventions

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

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Royal College of Surgeons, Ireland

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• Dixi Medical

  collaborator UNKNOWN

• ARTTIC

  collaborator UNKNOWN

• University of Erlangen-Nürnberg Medical School

  lead OTHER

Principal Investigators

• Hajo Hamer, MD PhD · Universitätsklinikum Erlangen Neurologische Klinik

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-31

Primary Completion

2020-06-25

Completion

2020-07-25

Countries

• Germany

Study Locations