NCT04099823

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2019Jan 2027

First Submitted

Initial submission to the registry

September 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7.2 years

First QC Date

September 17, 2019

Last Update Submit

January 2, 2026

Conditions

HydrocephalusAlzheimer Disease

Outcome Measures

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.

    At the time of MR exam, approximately one hour

Secondary Outcomes (2)

  • Volume of CSF spaces

    At the time of MR exam, approximately one hour

  • White matter disease

    At the time of MR exam, approximately one hour

Study Arms (1)

MR brain

OTHER

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.

Other: MRI screening formDiagnostic Test: Urine pregnancy testDiagnostic Test: MR brain

Interventions

MRI screening formOTHER

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.

MR brain
Urine pregnancy testDIAGNOSTIC_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
MR brainDIAGNOSTIC_TEST

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.

MR brain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

HydrocephalusAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Petrice Cogswell, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suson (Sue) Walsh

CONTACT

507-293-0039Walsh.Suson@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 23, 2019

Study Start

October 31, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)