Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Primary study objective:

• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.

Secondary study objectives:

• Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.
• Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.
• Determining hemodynamic imaging patterns that can be tested as novel imaging markers.

Study Overview

• Status: Recruiting
• Conditions: Brain Blood Flow Impairment
• Intervention / Treatment: Other: Advanced imaging investigation

Detailed Description

Primary study objective:

• to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.

Secondary study objectives:

• To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.
• To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.

4.2 Outcomes

Outcomes of the project:

Primary endpoint:

To find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.

Secondary endpoints:

• Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)
• Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jorn Fierstra, MD, PhD; Phone Number: 0041 442553169; Email: jorn.fierstra@usz.ch
• Study Contact Backup: Name: Luca Regli, Professor; Phone Number: 0041442552992; Email: Luca.regli@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Recruiting
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neurosurgical patients with the potential to have altered blood flow to the brain

Description

Inclusion criteria

Patients:

• Male and Female subjects >18 years of age
• Written informed consent after participants' information. Foreign speaking patients should be accompanied by a person with sufficient German language proficiency to act as a translator

• Neurosurgical diseases with the potential to alter blood flow to the brain:

  • Cerebrovascular disease
  • Brain tumors
  • Normal Pressure Hydrocephalus

Healthy subjects:

• Male and Female subjects >18 years of age
• Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator

Exclusion criteria:

Patients:

• Unwilling or unable to co-operate with breathing maneuvers
• Respiratory or cardiac limitations to breathing through a mask
• Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
• Standard contraindications for MRI scanning
• Verbal confirmed pregnancy
• Known multiple intracranial diseases
• Presence of intracranial hemorrhage within the last 3 months
• Symptomatic increased intracranial pressure

Healthy subjects:

• Unwilling or unable to co-operate with breathing maneuvers
• Respiratory or cardiac limitations to breathing through a mask
• Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
• Standard contraindications for MRI scanning
• Verbal confirmed pregnancy
• Anamnesticly a history of neurological disease or current neurological deficits.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neurosurgical patients; • Neurosurgical diseases with the potential to alter blood flow to the brain: Cerebrovascular disease; Brain tumors; Normal Pressure Hydrocephalus	Other: Advanced imaging investigation; MRI imaging
Healthy subjects; Male and Female subjects >18 years of age; Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator	Other: Advanced imaging investigation; MRI imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.	blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements	5 years

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-02314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No