MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04099823
• Other study ID #: 19-005910
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: Suson (Sue) Walsh
• Phone: 507-293-0039
• Email: Walsh.Suson[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Hydrocephalus

Intervention

Other:
• MRI 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 Test:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the time of MR exam, approximately one hour
Secondary	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.	At the time of MR exam, approximately one hour
Secondary	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.	At the time of MR exam, approximately one hour

External Links

•   Mayo Clinic Clinical Trials