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NCT Number: NCT04099823

MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Petrice Cogswell, MD

PRINCIPAL_INVESTIGATOR

Suson (Sue) Walsh

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

MRI screening form

Other

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.

Urine pregnancy test

Diagnostic Test

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

MR brain

Diagnostic Test

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.

Primary outcomes

  1. CSF flow measurement

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

    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.

Secondary outcomes

  1. Volume of CSF spaces

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

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

  2. White matter disease

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

    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.

Study contacts

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

Suson (Sue) Walsh

CONTACT

[email protected]

507-293-0039

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2019
Registry last updated
Jan 6, 2026

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.

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