Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— ROMUS  

Official title:

Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403570
• Other study ID #: T125/2014
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

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

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