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MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics

MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics and Association of Intracranial CSF Flow With Brain Function

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04099823
Enrollment
50
Registered
2019-09-23
Start date
2019-10-31
Completion date
2027-01-31
Last updated
2026-01-06

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

Conditions

Hydrocephalus, Alzheimer Disease

Brief summary

The Researchers are trying to test a MR imaging method for detection of Cerebral Spinal Fluid (CSF) flow in the brain to help diagnosis and better understand diseases that affect brain function.

Detailed description

The purpose of this research is to figure out if MR imaging can detect movement of CSF (fluid around the brain) to help better diagnosis and understand the cause of diseases that affect brain function. We are doing this research study to find out if movement of CSF is different between healthy adults and those with a disease that affects brain function.

Interventions

OTHERMRI screening form

Participants will be asked to complete a MRI screening form to check for the presence of metallic implants and materials. People with pacemakers, aneurysm clips, and cochlear implants, or metal/foreign objects in their eyes cannot have an MRI and will not be able to participate in the study.

DIAGNOSTIC_TESTUrine pregnancy test

Pre-menopausal females will be asked if they think they may be pregnant. If yes, a urine pregnancy test will be performed.

DIAGNOSTIC_TESTMR brain

You will be asked to lie down on the bed of the MRI scanner. Then a MRI coil/antenna will be placed over your head. This will allow us to get clearer pictures of the tissue of interest. The MRI machine makes loud knocking sounds. Because of this you will be asked to wear earplugs. You will receive a squeeze ball alarm in case you need urgent help. We will be able to talk with you and hear you during the MRI exam. The entire MRI scan will last about 45-60 minutes. The MR exam will include standard clinical images as well as the CSF flow imaging.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

Inclusion criteria

* A healthy control will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination. * Patients who have a suspected diagnosis of altered CSF dynamics including but not limited to normal pressure hydrocephalus will be referred to Dr. Cogswell by their care team to be included in the study. Conditions of altered CSF dynamics include obstructive and non-obstructive hydrocephalus and may be associated with headaches and/or decreased cognitive function. * Similarly, patients with impaired cognitive function including but not limited to Alzheimer's disease will be referred to Dr. Cogswell by their care team to be included in the study.

Exclusion criteria

* Subjects with non-MRI compatible devices * required sedation * women who may be pregnant will be excluded. * The first 10 subjects with normal pressure hydrocephalus will not have previously been shunted.

Design outcomes

Primary

MeasureTime frameDescription
CSF flow measurementAt the time of MR exam, approximately one hourCSF flow will be measured in participants and compared between those with unimpaired brain function and those with clinical diagnosis of a disease that affects brain function, such as Alzheimer's disease and normal pressure hydrocephalus.

Secondary

MeasureTime frameDescription
Volume of CSF spacesAt the time of MR exam, approximately one hourUsing standard clinical imaging techniques and computer-automated segmentation methods, the intra and extra-ventricular CSF volume will be measured for each subject.
White matter diseaseAt the time of MR exam, approximately one hourUsing standard clinical imaging techniques and computer-automated algorithms, the volume of white matter disease (hyperintense foci in the white matter on T2-weighted MR sequences) will be measured in each subject.

Countries

United States

Contacts

Primary ContactSuson (Sue) Walsh
Walsh.Suson@mayo.edu507-293-0039

Outcome results

None listed

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