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

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ClinicalTrials.gov Identifier: NCT02403570
Recruitment Status : Unknown
Verified October 2016 by Hannu Aronen, Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : March 31, 2015
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hannu Aronen, Turku University Hospital

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Chronic Progressive Other: Brain MRI

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
Study Start Date : February 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403570


Contacts
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Contact: Hannu Aronen, M.D., Ph.D. +358 2 3133896 hannu.aronen@utu.fi

Locations
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Finland
Division of Clinical Neurosciences, Turku University Hospital Recruiting
Turku, Finland, FI-20520
Contact: Hannu Aronen, M.D., Ph.D.    +358 2 3133896    hannu.aronen@utu.fi   
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Hannu Aronen, M.D., Ph.D. Turku University Hospital, Department of Diagnostic Radiology

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Responsible Party: Hannu Aronen, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02403570     History of Changes
Other Study ID Numbers: T125/2014
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Hannu Aronen, Turku University Hospital:
Multiple Sclerosis, MRI, rotating frame

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases