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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02403570
Other study ID # T125/2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date December 31, 2016

Study information

Verified date March 2021
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Brain MRI


Locations

Country Name City State
Finland Division of Clinical Neurosciences, Turku University Hospital Turku

Sponsors (1)

Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
Primary 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 One year
Secondary MR relaxation values and clinical markers 0 Aim is to study the correlation between MR relaxation values and clinical markers of MS at baseline Baseline
Secondary 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 One year
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