Recruiting

Observational StudyMR Evaluation of Cerebrospinal Fluid (CSF) Dynamics

Sponsor:

Mayo Clinic

Code:

NCT04099823

Conditions

Hydrocephalus

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MRI screening form

Urine pregnancy test

MR brain

Study Details

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.

Conditions

Hydrocephalus

Alzheimer Disease

Study ID

NCT04099823

Start date

Oct 31, 2019

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

MRI screening form

Urine pregnancy 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

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 outcome measure

CSF flow measurement [ Time Frame: At the time of MR exam, approximately one hour ]

Central Contacts and Locations

Central contacts

Suson (Sue) Walsh

507-293-0039 Walsh.Suson@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Suson (Sue) Walsh

Walsh.Suson@mayo.edu

Principal Investigator:

Petrice Cogswell, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-06.