Glymphatic Kinetics In Healthy Adult Volunteers

NCT03218111 | Completed

• 1 other identifier: 1609017536
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Glymphatic network; healthy; central nervous system

Outcome Measures

Primary Outcomes (1)

• Drug distribution over time

  The drug distribution of gadolinium contrast throughout the Central Nervous System over time (12 hours)

  6 time-points over 12 hours

Study Arms (1)

Healthy Normal Subjects

OTHER

Healthy normal subjects 20-80 years old. All subjects will undergo the same procedures: intrathecal injection, using CT-guidance, with an MRI contrast. After injection subjects will undergo six sessions of MR imaging over a 10-12 hour period

Other: MR Imaging; Other: CT-guidance

Interventions

MR Imaging OTHER

All subjects will undergo six sessions of MR imaging over a 10-12 hour period

Healthy Normal Subjects

CT-guidance OTHER

All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.

Healthy Normal Subjects

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Biogen: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• J. Levi Chazen, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 14, 2017
• Study Start: February 6, 2017
• Primary Completion: February 6, 2018
• Study Completion: February 8, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)