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Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04668261
Enrollment
400
Registered
2020-12-16
Start date
2021-01-01
Completion date
2027-11-01
Last updated
2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Blood Flow Impairment

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.

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.

Interventions

OTHERAdvanced imaging investigation

MRI imaging

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.5 yearsblood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements

Countries

Switzerland

Contacts

Primary ContactJorn Fierstra, MD, PhD
jorn.fierstra@usz.ch0041 442553169
Backup ContactLuca Regli, Professor
Luca.regli@usz.ch0041442552992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026