Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis (ROMUS)

March 2, 2021 updated by: Hannu Aronen, Turku University Hospital
The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging. In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

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

  • Finland
      • Turku, Finland, FI-20520
        • Division of Clinical Neurosciences, Turku University Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

MS patients with relapsing-remitting or secondary progressive MS will be recruited from amongst the MS patients in the neurological outpatient policlinics in the Hospital District of Southwestern Finland.

Description

Inclusion Criteria:

  • The diagnosis of relapsing remitting MS made according to the Poser, McDonald's or revised McDonald's criteria (Group I) before participating in the study
  • Initial MS diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (Group II).
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • Any other autoimmune disease than MS requiring immunomodulatory or immunosuppressive medication
  • High-dose corticosteroid treatment within 30 days before participating in the study
  • Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
  • Any psychiatric condition that compromises the subject's ability to participate in the study
  • Infections: Patient must not have an uncontrolled serious infection
  • No contraindications for MRI (cardiac pacemaker, intracranial clips etc)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple Sclerosis
Brain MRI using advanced MR techniques
Other: Brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR relaxation values 0
Time Frame: Baseline
Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS at baseline
Baseline
MR relaxation values 1
Time Frame: One year
Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS after one year follow-up
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR relaxation values and clinical markers 0
Time Frame: Baseline
Aim is to study the correlation between MR relaxation values and clinical markers of MS at baseline
Baseline
MR relaxation values and clinical markers 1
Time Frame: One year
Aim is to study the correlation between MR relaxation values and clinical markers of MS after one year follow up
One year

Collaborators and Investigators

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

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Hannu Aronen, M.D., Ph.D., Turku University Hospital, Department of Diagnostic Radiology

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

February 1, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T125/2014

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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