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RecruitingNCT04099823Updated Jan 6, 2026

MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics

An interventional study of MRI screening form and Urine pregnancy test in Hydrocephalus and Alzheimer Disease, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2019; still recruiting 6 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hydrocephalus
  • Alzheimer Disease
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In context

Hydrocephalus

210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 105 interventional studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    MR brain

    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. Pre-menopausal females will be asked if they think they may be pregnant. If yes, a urine pregnancy test will be performed. Those who meet eligibility criteria for the study and have agreed to participate will be taken to the MRI suite when MR imaging of the brain will be performed.

    Other: MRI screening form · Diagnostic Test: Urine pregnancy test · Diagnostic Test: MR brain

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.

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What researchers measure

Primary outcomes

  1. CSF flow measurement

    CSF 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.

    Time frame: At the time of MR exam, approximately one hour

Secondary outcomes

  1. Volume of CSF spaces

    Using standard clinical imaging techniques and computer-automated segmentation methods, the intra and extra-ventricular CSF volume will be measured for each subject.

    Time frame: At the time of MR exam, approximately one hour

  2. White matter disease

    Using 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.

    Time frame: At the time of MR exam, approximately one hour

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04099823
Lead sponsor
Mayo Clinic
Responsible party
Petrice M. Cogswell (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 23, 2019
Start date
Oct 31, 2019
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 6, 2026

Study contacts

Suson (Sue) Walsh
Contact
Walsh.Suson@mayo.edu
507-293-0039
Petrice Cogswell, MD
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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