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

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

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

Study Overview

• Status: Completed
• Conditions: Spontaneous Subarachnoid Hemorrhage
• Intervention / Treatment: Device: NeMo Probe

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69221
    • Department of Neurosurgery, University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NeMoProbe; The NeMo System is used for intracranial pressure (ICP) and brain temperature monitoring, as well as the determination of the brain tissue oxygenation saturation (SbtO2) and cerebral blood flow. The sensors for NIRS are implemented into a conventional brain tissue probe for ICP monitoring (NeMo Probe).	Device: NeMo Probe; A new minimal-invasive brain tissue probe applying near infrared spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the feasibility of the neuromonitoring system and accuracy of the measurement values	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):	Day 90 after Removal of Medical Device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage	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.	Day 90 after Removal of Medical Device

Collaborators and Investigators

• Sponsor: NeMoDevices AG
• Investigators: Principal Investigator: Martin Seule, MD, Department of Neurosurgery, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: CIV-12-04-006261