MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MRI screening form
Other interventionParticipants 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.
Urine pregnancy test
Diagnostic testPre-menopausal females will be asked if they think they may be pregnant. If yes, a urine pregnancy test will be performed.
MR brain
Diagnostic testYou 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: MR brainOther 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At the time of MR exam, approximately one hourSecondary outcomes
1
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.
Time frame
At the time of MR exam, approximately one hour2
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.
Time frame
At the time of MR exam, approximately one hourSponsors and contacts
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Source ClinicalTrials.gov