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CompletedNCT02403570ROMUSUpdated Mar 3, 2021

Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis

An observational study in Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Chronic Progressive, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Turku University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
21
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Chronic Progressive

Keywords

  • Multiple Sclerosis, MRI, rotating frame
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 286 studies on the registry; 66 are open to participants now.

Browse Turku University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • Multiple Sclerosis

    Brain MRI using advanced MR techniques

    Other: Brain MRI

Interventions

  • OtherBrain MRI
06

What researchers measure

Primary outcomes

  1. MR relaxation values 0

    Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS at baseline

    Time frame: Baseline

  2. MR relaxation values 1

    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

    Time frame: One year

Secondary outcomes

  1. MR relaxation values and clinical markers 0

    Aim is to study the correlation between MR relaxation values and clinical markers of MS at baseline

    Time frame: Baseline

  2. MR relaxation values and clinical markers 1

    Aim is to study the correlation between MR relaxation values and clinical markers of MS after one year follow up

    Time frame: One year

07

Study locations

1 site
  • Division of Clinical Neurosciences, Turku University Hospital
    Turku, FI-20520, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02403570
Lead sponsor
Turku University Hospital
Responsible party
Hannu Aronen (Professor, Turku University Hospital) — Principal investigator
First posted
Mar 31, 2015
Start date
Feb 2015
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Mar 3, 2021

Study contacts

Hannu Aronen, M.D., Ph.D.
principal investigator · Turku University Hospital, Department of Diagnostic Radiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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