MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics

Official title

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

Overview

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

• 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.
• Diagnostic test 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 sta

Primary outcome measures

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

Secondary outcome measures (2)

• Volume of CSF spaces [Time frame: At the time of MR exam, approximately one hour]
• White matter disease [Time frame: At the time of MR exam, approximately one hour]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Mayo Clinic — Rochester

Identifiers

NCT: NCT04099823 · 19-005910

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗