Glymphatic MRI Study

June 5, 2024 updated by: Juan Piantino, Oregon Health and Science University

Evaluation of Glymphatic Function With MRI

This study aims at identifying neuroimaging markers of glymphatic function in humans.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy adults

Description

Inclusion Criteria:

  • Ability to undergo MRI without anesthesia
  • Calculated GFR greater or equal to 60 mL/min/1.73 m2

Exclusion Criteria:

  • Inability to obtain consent
  • Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
  • Known allergic or hypersensitivity reactions to gadolinium
  • Three or more drug allergies from separate drug classes
  • Recent or expected beed for imaging with iodinated contrast
  • Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe
  • History of neurosurgical procedure or cervical surgery
  • Current use of anticoagulation medications
  • Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast enhancement
Time Frame: 2 weeks
Measurement of contrast intensity in brain parenchyma
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IT Gadolinium Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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