NCT04668261 Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
| NCT ID | NCT04668261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Brain Blood Flow Impairment |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2021-01-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04668261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Blood Flow Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04668261 currently recruiting?
Yes, NCT04668261 is actively recruiting participants. Contact the research team at jorn.fierstra@usz.ch for enrollment information.
Where is the NCT04668261 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT04668261 clinical trial?
NCT04668261 is sponsored by University of Zurich. The trial plans to enroll 400 participants.