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Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

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ClinicalTrials.gov Identifier: NCT04668261
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment
Brain Blood Flow Impairment 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 Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2027
Groups and Cohorts
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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


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neurosurgical patients with the potential to have altered blood flow to the brain
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668261


Contacts
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Contact: Jorn Fierstra, MD, PhD 0041 442553169 jorn.fierstra@usz.ch
Contact: Luca Regli, Professor 0041442552992 Luca.regli@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04668261    
Other Study ID Numbers: 2020-02314
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No