Skip to main content
OpenTrials
Completed

NCT Number: NCT02403570

Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Clinical Neurosciences, Turku University Hospital

Turku, FI-20520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brain MRI

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Acronym: ROMUS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2015
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.