Glymphatic Kinetics In Healthy Adult Volunteers

Completed · Not applicable

Conditions studied: Healthy

In brief

This study is being done in order to see how gadolinium-based MRI contrast (Magnevist) travels through the central nervous system (CNS) when injected through the spinal column, and to compare differences between two age groups (age 20-50, and 51-80). This will allow investigators to evaluate how much contrast has crossed into the tissue surrounding the brain. Such information will help investigators determine whether this kind of contrast can be used to model how other drugs might travel through the CNS and evaluate its use as an illustrative imaging marker that mirrors the glymphatic system.

Key facts

Study ID

NCT03218111

Run by

Weill Medical College of Cornell University

People needed

19

Starts

2017-02-06

Expected to finish

2018-02-08

Last updated by the study team

2018-02-12

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Deemed healthy and able to undergo MR imaging by the Site Investigator, based on screening assessments:
• medical history, physical examination, vital signs, and clinical laboratory values
• Age 20-80
• Willing to undergo multiple imaging sessions
• Normal screening MRI to exclude subjects with a mass (e.g., disk herniation), congenital malformation (e.g., Chiari malformation), or an abnormal curvature of the spine that could alter CSF flow.
• If female of childbearing age: negative pregnancy test
• Normal Basic metabolic Panel and CBC (Platelet count > 150,000; Hb >8)
• Willing to undergo LP procedure. -

You may not qualify if…

• Kyphosis
• Claustrophobia
• Chronic cough
• Active infection with fever (>101.5), to limit risk of meningitis. Infections could include pneumonia, pharyngitis, skin infection, UTI, etc.
• History of CNS tumor or anomaly
• History of radiation therapy to the CNS
• History of hydrocephalus
• Abnormality on MRI that could impede CSF flow (i.e., extruded disk)
• Laboratory finding of prolonged coagulation times
• Pregnant/nursing
• Prior spine or brain surgery or trauma
• Inability to lay still and supine
• Recent lumbar puncture within 1 month of planned LP.

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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