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MR Evaluation for Brain Health
N/A
Recruiting
Led By Petrice Cogswell, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Must not have
Subjects requiring sedation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of mr exam, approximately one hour
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to detect Cerebral Spinal Fluid (CSF) flow in the brain to help with diagnosis and understanding of diseases that affect brain function.
Who is the study for?
This trial is for healthy individuals and those with suspected altered CSF dynamics, such as hydrocephalus or cognitive impairments like Alzheimer's. Participants should not have conditions affecting brain function or memory issues. Pregnant women, people needing sedation for MRI, or those with non-MRI compatible devices cannot join.
What is being tested?
The study is testing a new MR imaging method to observe the flow of cerebrospinal fluid (CSF) in the brain. This could improve diagnosis and understanding of conditions like Alzheimer's Disease and Hydrocephalus that impact brain function.
What are the potential side effects?
As this trial involves standard MRI procedures, side effects are minimal but may include discomfort from lying still during the scan or reactions to contrast agents if used—like mild pain, coldness at the injection site, or light-headedness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy with no brain function issues or problems with concentration, memory, balance, or coordination.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need medication to help me stay calm or asleep.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of mr exam, approximately one hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of mr exam, approximately one hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CSF flow measurement
Secondary study objectives
Volume of CSF spaces
White matter disease
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MR brainExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Urine pregnancy test
2006
Completed Phase 3
~120
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,299 Total Patients Enrolled
1 Trials studying Hydrocephalus
2 Patients Enrolled for Hydrocephalus
Petrice Cogswell, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication to help me stay calm or asleep.You have medical devices that are not safe for MRI scans.I have normal pressure hydrocephalus and have not had a shunt placed.I am healthy with no brain function issues or problems with concentration, memory, balance, or coordination.I am suspected to have a condition affecting the flow of brain fluid, possibly leading to headaches or memory problems.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: MR brain
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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