Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Interventions: Other: Brain MRI

• Registration Number: NCT02403570
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-31
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis	Brain MRI	Brain MRI using advanced MR techniques

Primary Outcome Measures

Name	Time	Method
MR relaxation values 0	Baseline	Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS at baseline
MR relaxation values 1	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

Name	Time	Method
MR relaxation values and clinical markers 1	One year	Aim is to study the correlation between MR relaxation values and clinical markers of MS after one year follow up
MR relaxation values and clinical markers 0	Baseline	Aim is to study the correlation between MR relaxation values and clinical markers of MS at baseline

Trial Locations

Locations (1)

Division of Clinical Neurosciences, Turku University Hospital; 🇫🇮 Turku, Finland