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Completed

NCT Number: NCT01801306

A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy

To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values.

To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis

Completed

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Key information

Conditions

Spontaneous Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, University Hospital Heidelberg

Heidelberg, 69221, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18-75 years (inclusive)
  • Patients with high-grade subarachnoid hemorrhage (WFNS 4-5)
  • Decreased level of consciousness with the need for intracranial pressure monitoring
  • Successful exclusion of the ruptured aneurysm with clipping or coiling
  • Women of childbearing potential must have a negative serum pregnancy test
  • Written informed consent obtained by a legal representative

Exclusion criteria

  • Significant kidney and/or liver disease
  • Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure > NYHA II)
  • Cerebrospinal fluid infection or signs of meningoencephalitis
  • Acute respiratory distress syndrome (ARDS), pulmonary edema
  • Preexisting coagulation disorder
  • Patients with current alcohol or drug abusus or dependence
  • Patients with a history of hypersensitivity against indocyanine green or sodium iodine
  • Patients with thyroid disease causing hyperthyroidism
  • Breast-feeding women
  • Patients committed to an institution based on official directive or court order

Treatment and study plan

NeMo Probe

Device

A new minimal-invasive brain tissue probe applying near infrared spectroscopy

Primary outcomes

  1. To assess the feasibility of the neuromonitoring system and accuracy of the measurement values

    Time frame: Day 90 after Removal of Medical Device

    Feasibility: User acceptance rate in comparison to conventional probes for ICP-monitoring. The following parameters will be analysed:

    • Incidence of concerns of users in relation to the installation of the NeMo System
    • Incidence of concerns of users in relation to the function of the NeMo System Incidence of concerns of users in relation to the removal of the NeMo System
    • User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional probes for ICP monitoring Accuracy of measurement values: Results from repeated measurements of mttICG, CBV, and CBF.

    Safety endpoints:

    -Adverse events profile (including adverse device effects): Incidence of complications (infections, brain tissue damage, hemorrhage) in comparison to historical series (conventional probes for ICP-monitoring):

Secondary outcomes

  1. To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage

    Time frame: Day 90 after Removal of Medical Device

    Results concerning the response to cortical spreading depolarization (CSD) monitored with electrocorticography (ECoG):

    Increase of brain tissue oxygenation (SbtO2), total hemoglobin (dHbtotal, aHbtotal), CBV, CBV Hb and CBF >20% Decrease of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF >20% Changes of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF <20%

    Results concerning the sensitivity and specificity to detect delayed cerebral ischemia (DCI) monitored with ptiO2 and MD:

    Correlation of CBF values <15 ml/100g/min with defined criteria for DCI (ptiO2 <15 mmHg, Gluc brain<0.7 mmol/l, Lactate-Pyruvate-Ratio >40), number of false negative and false positive events, Receiver Operating Characteristic (ROC) curve.

Sponsors and collaborators

Lead sponsor

NeMoDevices AG

Industry

Registry information

Official study title

A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2013
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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