Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT04668261
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04668261
Study Brief:
Protocol Section:
NCT04668261