Back to resultsMR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
Primary Purpose
Hydrocephalus, Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI screening form
Urine pregnancy test
MR brain
Sponsored by
About this trial
This is an interventional diagnostic trial for Hydrocephalus
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.
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MR brain
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04099823
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Alzheimer Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR brain
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MRI screening form
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine pregnancy test
Intervention Description
Pre-menopausal females will be asked if they think they may be pregnant. If yes, a urine pregnancy test will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
MR brain
Intervention Description
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 Information:
Title
CSF flow measurement
Description
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 Outcome Measure Information:
Title
Volume of CSF spaces
Description
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
Title
White matter disease
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suson (Sue) Walsh
Phone
507-293-0039
Email
Walsh.Suson@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petrice Cogswell, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suson (Sue) Walsh
Email
Walsh.Suson@mayo.edu
First Name & Middle Initial & Last Name & Degree
Petrice Cogswell, MD
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
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