Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques

December 14, 2021 updated by: University Hospital, Basel, Switzerland
This study is to assess the variation in the measurements of myelin sensitive MRI techniques in both white and grey matter in the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Magnetization Transfer Imaging (MTI) permits the assessment of the integrity of macromolecules in brain tissue, such as myelin and cellular/axonal membrane components.

Multi-echo Susceptibility-Based imaging (SBI) provides quantitative susceptibility maps and T2* maps that - when combined - permit the disentanglement of myelin from iron and various phases of myelin degradation.

Myelin Water Imaging (MWI) quantifies the water trapped between myelin layers by separating the multiple water components in T2 relaxometry data. In fact, the presence of myelin on water pools bound to it provokes a loss in magnetic resonance (MR)-signal coherence, which is more rapid than the one characterizing the water pools located within the axons or in the cytoplasm.

A method based on a spiral acquisition that achieves a myelin-specific signal in clinically compatible scan times is currently applied: T1 relaxometry (quantitative T1, qT1) - which measures the time that a perturbed nuclear spin distribution needs to get back to equilibrium in the longitudinal plane- is sensitive to a number of components of the brain tissue such as myelin, axonal diameter and the overall architectural organization of the brain tissue.

Finally, multi-shell diffusion allows the application of mathematical models of diffusion compartments, which in part are influenced by myelin integrity.

The goal of this study is to assess the stability of these techniques in scan-rescan experiment on 20 healthy subjects.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Neurologische Klinik und Poliklinik, University Hospital Basel

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

healthy subjects recruited by public announcements (i.e. advertisement/flyer) on the University Hospital's and the University's notice board

Description

Inclusion Criteria:

  • No neurological or psychiatric disorder

Exclusion Criteria:

  • Pregnancy
  • Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).
  • Inability to give consent.

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
analysis of variance between MTI, SBI, MWI, T1 relaxometry and multi-shell diffusion obtained in each subject in each of the 3 scan sessions
Time Frame: 1 hour total scan time (during a time period of max. 1 week)
statistical analysis of variance between MTI, SBI, MWI, T1 relaxometry and multi-shell diffusion obtained in each subject in each of the 3 scan sessions
1 hour total scan time (during a time period of max. 1 week)

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Cristina Granziera, Prof. Dr. med., Neurologische Klinik und Poliklinik, University Hospital Basel

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 (Actual)

February 5, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02826; me20Granziera3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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