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NCT Number: NCT04668261

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8032, Switzerland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advanced imaging investigation

Other

MRI imaging

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jorn Fierstra, MD, PhD

CONTACT

[email protected]

0041 442553169

Luca Regli, Professor

CONTACT

[email protected]

0041442552992

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Dec 16, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.