Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Brain Blood Flow Impairment Clinical Trial

Official title:

Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668261
• Other study ID #: 2020-02314
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: November 1, 2027

Study information

• Verified date: December 2020
• Source: University of Zurich
• Contact: Jorn Fierstra, MD, PhD
• Phone: 0041 442553169
• Email: jorn.fierstra[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Blood Flow Impairment

Intervention

Other:
• Advanced imaging investigation
MRI imaging

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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